U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
There is a chance that the ball plunger could fall out during surgery and fall into the surgical site. there could be a delay in surgery to remove the ball plunger. if the problem was undetected, the ball plunger could remain in the patient causing pain and potentially necessitating subsequent surgery for removal.
Acción
Zimmer sent an URGENT MEDICAL DEVICE RECALL LETTER dated October 21, 2010, to all affected customers. The letter identified the product, the problem, the action to be taken by the customer.
Customers were instructed to:
Inspect their inventory, stop using the device, and place it in quarantine.
Contact Zimmer Customer Service at 1-800-774-6368 to obtain a return authorization number.
Complete the Inventory Return Certification form and fax a copy to (952) 837-6958, or scan and email to qualitycompliance@zimmer.com.
Return the recalled product along with the original completed Return Certification Form to:
Zimmer Spine, Inc.
Attn: RA Receiving
5301 Riata Park Ct.
Austin, Texas 78727
For questions regarding this recall call Zimmer Spine Customer Service at 1-866-774-6368.
.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Intramedullary Fixation Rod and Accessories - Product Code HSB
Causa
The firm has determined that two lots of this instrument were inappropriately manufactured by the supplier. the manufacturing process created a step in the lumen which impedes the lag screw retaining shaft from passing through the lumen without the use of excessive force.
Acción
The firm sent Correction and Removal Notification Immediate Response Required letters via email to consignees. The letter identified the affected product and the reason for the recall. The letters also discussed the clinical implications and required actions. Customers are to complete the inventory certification form and user facility documentation form. Each of the affected accounts will be provided with a new instrument, manufactured with the correct lumen diameter and will secure and return the affected instruments per the attached notification, along with the completed inventory certification form. If any further information is needed, customers are to contact Aimee Wood at 574-372-4463.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Ureteral Stent - Product Code FAD
Causa
The firm received a customer complaint that a box labeled as universa firm stents but the box actually contained universa soft stents. the inner product label is correct but the outer box is wrong.
Acción
The firm sent URGENT: RECALL NOTICES dated 10/18/2010 to its direct accounts. The notice identified the affected product and instructed firms to pull the recalled product from stock and isolate it. Customers are to complete the form and e-mail or fax the form back to Cook. Product should be returned to the recalling firm using the Return Goods Authorization number. Cook Urological will credit customer accounts upon receipt of the returned product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
High Frequency Ventilator - Product Code LSZ
Causa
Product software coding error may compromise patient safety.
Acción
Customers were notified by an "Urgent: Medical Device Recall or Correction" letter starting 10/22/10. The letter identified the product and described the issues. Customers were given the option of either returning their ventilator(s) for rework or to receive installation/re-test instructions with an upgrade kit to rework themselves. The letter states that all Life Pulse ventilators in clinical use must be upgraded and there is no charge for the software upgrade.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Radioimmunoassay, human chorionic gonadotropin - Product Code JHI
Causa
Beckman coulter has confirmed that non-reproducible falsely elevated test results may occur when using the access total bhcg assay. these elevated results are often attributed to pre-analytical factors and are particularly noted at the low end of the analytical measuring range.
the role of preanalytical factors in laboratory testing has been described in a variety of published literature.
Acción
Beckman Coulter sent an Urgent Product Corrective Action letter dated November 11, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:.
" Evaluate current laboratory protocols to ensure the necessary procedures are in place for identifying and mitigating falsely elevated test results.
" Follow the sample handling instructions provided in the Access Total ¿hCG Instruction for Use (IFU).
" Review the enclosed pre-analytical sample handling information bulletins:
1. The Role of Preanalytical Factors in Chemistry and Immunoassay Testing (P/N A34880A).
2. Sample Handling Makes a Difference (P/N A28226A).
" At the discretion of the laboratory director, any total ¿hCG result that is questioned due to lack of clinical correlation should be repeated.
NOTE: Due to the clinical utility of the Access Total ¿hCG assay as a biomarker of pregnancy, Beckman Coulter feels it is unnecessary to require a review of all previously obtained Access Total ¿hCG test results. The Access Total ¿hCG assay is intended as a marker for pregnancy at the time of testing. A discrepant or questionable result would have been brought to the attention of the laboratory. The pregnancy status of a patient at this point, post testing, would be known to the patient and the physician.
" Please share this information with your laboratory staff and your phlebotomy director and/or phlebotomy staff and retain this notification as part of your laboratory Quality System documentation.
" Complete and return the enclosed response form within ten days so they can be assured that this important notification has been received.
If you have any questions regarding this notification, please contact the Customer Support Center on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support or call
1-800-854-3633 in the United States and Canada. Outside the United States and Canada
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Differential Cell Counter - Product Code GKZ
Causa
A labeling error resulted in the specimen age stability and the prepared sample stability being stated incorrectly in the instructions for use. there is no impact to the product safety or functionality.
Acción
An Urgent: Product Corrective Action letter dated, September 27, 2010, was sent to customers. The letter identified the affected product and stated the reasons for the recall. Customers were also asked to take the following actions:
ACTION/RESOLUTION
For issue 1: The specimen stability claims should be as follows:
- 48 hours for both % positives and absolute counts for the CD45/4/8/3 tube
- 24 hours for both % positives and absolute counts for the CD45/56/19/3 tube
For Issue 2: Results produced are not impacted when samples are prepared and run within the post collection time frames provided in the product instructions for use:
- Preparation within 72 hours of collection for the CD45/4/8/3 tube
- Preparation within 24 hours of collection for CD45/56/19/3 tube
Beckman Coulter requested consignees complete and return the enclosed response form within 10 days so they may maintain their records. The firm also asked that they share the information with laboratory staff, and retain this notification as part of their Quality System documentation.
Questions regarding the Product Corrective Action were directed to (800) 526-7694 in the United States or (800) 463-7828 in Canada. If outside the US or Canada, consignees were instructed to contact their local Beckman Coulter Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Differential Cell Counter - Product Code GKZ
Causa
A labeling error resulted in the specimen age stability and the prepared sample stability being stated incorrectly in the instructions for use. there is no impact to the product safety or functionality.
Acción
An Urgent: Product Corrective Action letter dated, September 27, 2010, was sent to customers. The letter identified the affected product and stated the reasons for the recall. Customers were also asked to take the following actions:
ACTION/RESOLUTION
For issue 1: The specimen stability claims should be as follows:
- 48 hours for both % positives and absolute counts for the CD45/4/8/3 tube
- 24 hours for both % positives and absolute counts for the CD45/56/19/3 tube
For Issue 2: Results produced are not impacted when samples are prepared and run within the post collection time frames provided in the product instructions for use:
- Preparation within 72 hours of collection for the CD45/4/8/3 tube
- Preparation within 24 hours of collection for CD45/56/19/3 tube
Beckman Coulter requested consignees complete and return the enclosed response form within 10 days so they may maintain their records. The firm also asked that they share the information with laboratory staff, and retain this notification as part of their Quality System documentation.
Questions regarding the Product Corrective Action were directed to (800) 526-7694 in the United States or (800) 463-7828 in Canada. If outside the US or Canada, consignees were instructed to contact their local Beckman Coulter Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Causa
The recall was initiated because beckman coulter confirmed access waste bottles that ruptured and expelled liquid waste, exposing the operator to the system liquid waste. over time, waste bottles can degrade, become brittle and potentially crack.
Acción
The recall communication was initiated on October 5, 2010 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access immunoassay Systems, UniCel DxC 600i Access, and Immunoassay Systems, Synchron LxI 725 Access Clinical Systems. The letter explains the problem identified, the impact, and actions required to be taken by customers. The letter instructs customers to inspect the waste bottle for signs of aging and deterioration.
New bottles are opaque white in color.
Signs of deterioration include:
o Any color change to the bottle (yellow, orange or pink)
o Cracking
o Crazing (spider web cracking)
Any defect that is not removed by routine cleaning is a sign of deterioration. It is important to routinely inspect the area nearest the handle and along all seams of the bottle. If upon inspection consignees detect any issues with their waste bottles, they were asked to contact Beckman Coulter Customer Service using the enclosed Replacement Order Form to obtain a new waste bottle, and keep this information should they require a replacement bottle in the future.
Consignees were also asked to share this information with laboratory staff and retain the notification as part of laboratory Quality System documentation. They should also complete and return the enclosed Product Corrective Action Response Form within 10 days so Beckman Coulter can be certain they received this important notification.
Beckman Coulter offers a service kit which may be used to replace the waste bottle and direct liquid waste to a floor drain. Beckman Coulter requires a consultation with consignees technical support representative to determine if their system can be fitted with a floor drain kit. If assistance is needed or consignees have any questions regarding this notification, they were asked to contact Technical Support at 1-800-854-3633 i
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Discrete Photometric Chemistry Analyzer for Clinical Use - Product Code JJE
Causa
The recall was initiated because beckman coulter confirmed access waste bottles that ruptured and expelled liquid waste, exposing the operator to the system liquid waste. over time, waste bottles can degrade, become brittle and potentially crack.
Acción
The recall communication was initiated on October 5, 2010 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access immunoassay Systems, UniCel DxC 600i Access, and Immunoassay Systems, Synchron LxI 725 Access Clinical Systems. The letter explains the problem identified, the impact, and actions required to be taken by customers. The letter instructs customers to inspect the waste bottle for signs of aging and deterioration.
New bottles are opaque white in color.
Signs of deterioration include:
o Any color change to the bottle (yellow, orange or pink)
o Cracking
o Crazing (spider web cracking)
Any defect that is not removed by routine cleaning is a sign of deterioration. It is important to routinely inspect the area nearest the handle and along all seams of the bottle. If upon inspection consignees detect any issues with their waste bottles, they were asked to contact Beckman Coulter Customer Service using the enclosed Replacement Order Form to obtain a new waste bottle, and keep this information should they require a replacement bottle in the future.
Consignees were also asked to share this information with laboratory staff and retain the notification as part of laboratory Quality System documentation. They should also complete and return the enclosed Product Corrective Action Response Form within 10 days so Beckman Coulter can be certain they received this important notification.
Beckman Coulter offers a service kit which may be used to replace the waste bottle and direct liquid waste to a floor drain. Beckman Coulter requires a consultation with consignees technical support representative to determine if their system can be fitted with a floor drain kit. If assistance is needed or consignees have any questions regarding this notification, they were asked to contact Technical Support at 1-800-854-3633 i
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Discrete Photometric Chemistry Analyzer for Clinical Use - Product Code JJE
Causa
The recall was initiated because beckman coulter confirmed access waste bottles that ruptured and expelled liquid waste, exposing the operator to the system liquid waste. over time, waste bottles can degrade, become brittle and potentially crack.
Acción
The recall communication was initiated on October 5, 2010 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access immunoassay Systems, UniCel DxC 600i Access, and Immunoassay Systems, Synchron LxI 725 Access Clinical Systems. The letter explains the problem identified, the impact, and actions required to be taken by customers. The letter instructs customers to inspect the waste bottle for signs of aging and deterioration.
New bottles are opaque white in color.
Signs of deterioration include:
o Any color change to the bottle (yellow, orange or pink)
o Cracking
o Crazing (spider web cracking)
Any defect that is not removed by routine cleaning is a sign of deterioration. It is important to routinely inspect the area nearest the handle and along all seams of the bottle. If upon inspection consignees detect any issues with their waste bottles, they were asked to contact Beckman Coulter Customer Service using the enclosed Replacement Order Form to obtain a new waste bottle, and keep this information should they require a replacement bottle in the future.
Consignees were also asked to share this information with laboratory staff and retain the notification as part of laboratory Quality System documentation. They should also complete and return the enclosed Product Corrective Action Response Form within 10 days so Beckman Coulter can be certain they received this important notification.
Beckman Coulter offers a service kit which may be used to replace the waste bottle and direct liquid waste to a floor drain. Beckman Coulter requires a consultation with consignees technical support representative to determine if their system can be fitted with a floor drain kit. If assistance is needed or consignees have any questions regarding this notification, they were asked to contact Technical Support at 1-800-854-3633 i
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
System,test,thyroglobulin - Product Code MSW
Causa
The recall was initiated because in addition to access tg sample diluent, an additional diluent, access wash buffer ii, was added to thyroglobulin instructions for use (ifu) for evaluation of samples having tg levels above the reportable range of the assay. when customers interchange between diluents there is an unacceptable shift in results. a median
difference of 16% (ranging from 14% to 23%) b.
Acción
The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 18, 2010, with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access Immunoassay Systems Thyroglobulin. The letter describes the product, problem and actions to be taken. The customers were instructed to:
1. Do not dilute elevated thyroglobulin samples with Wash Buffer II.
2. Do not run thyroglobulin patient samples using the onboard dilution feature on the UniCel DxI instrument.
3. Dilute elevated thyroglobulin samples only with Access Thyroglobulin Sample Diluent (REF 33866).
4. Review your patient result archives. Manually dilute and repeat the analysis of all elevated thyroglobulin samples that had previously been diluted with Wash Buffer II, using Access Thyroglobulin Sample Diluent instead.
5. A forthcoming version of the UniCel DxI Assay Protocol File (APF) will remove the Access Thyroglobulin onboard dilution assay (dTg) from the list of available onboard dilution assays.
6. The Access Tg product Instructions for Use will be updated to eliminate Wash Buffer II as an acceptable diluent for elevated thyroglobulin samples. Customers should update procedure manuals and other documents that your laboratory may have created which list Wash Buffer II as an acceptable diluent for elevated thyroglobulin samples.
In addition, customers were instructed to complete and return the enclosed PCA Response Form with in 10 days via fax to: 786-639-4000 or mail to: Beckman Coulter, Inc., 1000 Lake Hazeltine Drive, Chaska, MN 55318, Attn: Regulatory Affairs.
Customers with any technical questions regarding the Product Corrective Action were instructed to contact Beckman's Customer Support Center on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the US and Canada. Outside the US and Canada, customers were instructed to contact their local Be
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Lavage, jet - Product Code FQH
Causa
There is potential for a breach in sterility in the blister packaging. this can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
Acción
Stryker sent a Medical Device Recall Notification letter dated October 8, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to destroy and dispose of all affected product and to complete the business reply form and return to Stryker to receive replacement interpulse products at no charge.
For questions regarding this recall call (269) 323-7700.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Lavage, jet - Product Code FQH
Causa
There is potential for a breach in sterility in the blister packaging. this can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
Acción
Stryker sent a Medical Device Recall Notification letter dated October 8, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to destroy and dispose of all affected product and to complete the business reply form and return to Stryker to receive replacement interpulse products at no charge.
For questions regarding this recall call (269) 323-7700.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Lavage, jet - Product Code FQH
Causa
There is potential for a breach in sterility in the blister packaging. this can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
Acción
Stryker sent a Medical Device Recall Notification letter dated October 8, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to destroy and dispose of all affected product and to complete the business reply form and return to Stryker to receive replacement interpulse products at no charge.
For questions regarding this recall call (269) 323-7700.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Lavage, jet - Product Code FQH
Causa
There is potential for a breach in sterility in the blister packaging. this can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
Acción
Stryker sent a Medical Device Recall Notification letter dated October 8, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to destroy and dispose of all affected product and to complete the business reply form and return to Stryker to receive replacement interpulse products at no charge.
For questions regarding this recall call (269) 323-7700.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Lavage, jet - Product Code FQH
Causa
There is potential for a breach in sterility in the blister packaging. this can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
Acción
Stryker sent a Medical Device Recall Notification letter dated October 8, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to destroy and dispose of all affected product and to complete the business reply form and return to Stryker to receive replacement interpulse products at no charge.
For questions regarding this recall call (269) 323-7700.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Lavage, jet - Product Code FQH
Causa
There is potential for a breach in sterility in the blister packaging. this can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
Acción
Stryker sent a Medical Device Recall Notification letter dated October 8, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to destroy and dispose of all affected product and to complete the business reply form and return to Stryker to receive replacement interpulse products at no charge.
For questions regarding this recall call (269) 323-7700.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Lavage, jet - Product Code FQH
Causa
There is potential for a breach in sterility in the blister packaging. this can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
Acción
Stryker sent a Medical Device Recall Notification letter dated October 8, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to destroy and dispose of all affected product and to complete the business reply form and return to Stryker to receive replacement interpulse products at no charge.
For questions regarding this recall call (269) 323-7700.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
X-Ray CT Scanner - Product Code JAK
Causa
Incorrect dose calculation. the software that performs the pre-scan dose calculation uses an incorrect parameter for an exam plan using a tube voltage of 80kv or 100kv. this results in a pre-scan expected dose that is approximately 10% lower than what the displayed value should be when the scanner executes the exam plan.
Acción
Toshiba America Medical Systems (TAMS) issued notification to consignees 9/7/2010, via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS as proof of notification.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Introducer, catheter - Product Code DYB
Causa
Device has the potential to fracture and sheath separation during use.
Acción
The firm, Arstasis, initiated a market withdrawal and sent notification via letters dated October 19, 2010, to customers informing the customers that Arstasis is implementing a product improvement and will replace all existing inventory that the customer has on their shelf with the improved product. The customers were instructed to work closely with their local Arstasis territory manager to ensure that their product replacement is handled satisfactorily, and complete and return the PRODUCT REPLACEMENT and PRODUCT RETURN forms to Arstasis Customer Service via fax at 1-877-688-8417 or email to customerservice@arstasis.com.
If you have any questions or concerns, contact Customer Service toll free at 1-877-594-4545.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The firm has recieved complaints of imprecision and erroneous patient results for calcium on the cobas integra and cobas c 501 system using reagent lots 62601901 and 63020401.
Acción
The firm, Roche, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated October 11, 2010 to all consignees/customers via UPS(signature required) . The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the recalled product; discard from inventory according to their site's local regulations; complete and return the attached Faxback form via fax to 1-877-598-5705 even if they do not have the affected product, and file this letter for future reference.
The firm added lot 63020401 to the recall in 3/2011. The firm is mailing an URGENT MEDICAL DEVICE REMOVAL notice to customers that purchased that lot of product.
Please contact Roche Diagnostics Technical Support at 1-800-428-2336 if you have questions about the information contained in this letter.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
intraaortic balloon system - Product Code DSP
Causa
Superarrow flex iab catheter becomes stuck in the sheath, unable to move the iab catheter forward or backward, causing a delay in therapy, bleeding or arterial injury.
Acción
Arrow international initiated a voluntary recall on 12/21/10 by letter requesting users to discontinue use and return all unused 5800 Series IAB with SuperFlex Introducers to Arrow. This field action supercedes the Safety Alert IAB 'Stuck in Sheath' letter issued on 10/8/2010. Questions should be directed towards their local sales representative or the IABP support Line at 1-866-396-2111 or 1-617-389-6400.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Internal investigations have confirmed imprecision and erroneous patient results (up to 35% discrepant results) for specific lots of the calcium assay.
internal investigations revealed the presence of precipitate in the r2 of the affected calcium reagent lots. the precipitate observed was classified as o-cresolphthalein complexone (o-cpc), a reactive component of the calcium r2.
the root cau.
Acción
The firm, Roche, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated October 11, 2010 to all consignees/customers via UPS(signature required) . The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the recalled product; discard from inventory according to their site's local regulations; complete and return the attached Faxback form via fax to 1-877-598-5705 even if they do not have the affected product, and file this letter for future reference.
The firm added lot 63020401 to the recall in 3/2011. The firm is mailing an URGENT MEDICAL DEVICE REMOVAL notice to customers that purchased that lot of product.
Please contact Roche Diagnostics Technical Support at 1-800-428-2336 if you have questions about the information contained in this letter.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Real time nucleic acid amplification system - Product Code OOI
Causa
If the bar code is printed from the batch results screen, a wrong batch id may be printed, while the correct batch id is still assigned to the batch in the data repository of the mplc 2.0 software. this may result in sample mis identification. if printed from the ordering screens, the bar code is printed with the correct batch id.
Acción
The firm, Roche, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated November 04, 2010 to its customers. The letter described the product, problem and action to be taken. The customers were instructed to print batch ID barcode labels from the ordering or stage set up screens only; print Cooling Block barcode labels from the Post Elution Edit screen only; complete and return the attached UMDC Faxback Form for MagNA Pure LC 2.0 Instrument [UMDC 10-228] via fax to 1-877-551-7152 and file this correction notice for future reference. The firm plans to issue a software update in first quarter 2011.
If you have questions about the information contained in this UMDC, for Clinical customers, please contact Roche Molecular Diagnostics Technical Service at 1-800-526-1247; for Research customers, please contact Roche Applied Sciences Technical Service at 1-800-262-4911.