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
Candida species nucleic acid detection system - Product Code PII
Causa
Elevated levels of invalid results.
Acción
Customers were notified of the recall vie e-mail and certified mail on July 7, 2016, with an Urgent Medical Device Recall letter. Customers were asked to take the following actions:
1. Please examine your current inventory and determine whether you have any of the recalled lots listed. (a.) If you DO have cartridges from the recalled lots, please note the quantity of cartridges you have of each lot number on the attached form entitled T2Candida Cartridge Recall Customer Response Form (CRF). Please also immediately quarantine any cartridges from the indicated lots and do not use them. (b.) If you DO NOT have any cartridges from the recalled lots, please also note this in the space provided on the form
2. Send the completed CRF to T2Biosystems via e-mail to orders@t2biosystems.com or via fax to 781-240-0541. Your primary contact at T2 for all recall-related correspondence or questions is Georgette Yannios (gyannios@t2biosystems.com or 877-504-8282 Option 3). All product will be replaced at no charge to you as soon as possible.
3. Once T2 receives the CRF, we will issue a Return Material Authorization (RMA) number to you along with a FedEx shipping label. After you receive this RMA number and label, please follow the instructions provided with the RMA for shipment of cartridges back to T2 (please do not ship reagent trays as they are not subject to this action).
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
Kit, serological, positive control - Product Code MJX
Causa
The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. increased results may occur on both the negative and positive controls. the positive control, although showing elevated results, was still within acceptable performance.
Acción
The firm, Ortho Clinical Diagnostics, distributed "Important Product Correction Notification" letters (Ref. CL2016-129) dated 6/22/2016 and Confirmation of Receipts to their customers via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only). Foreign affiliates were informed by email (on 22 June 2016) of the issue and instructed to notify their consignees of the issue and required actions. All customers who received the affected product were instructed to immediately discontinue using and discard the affected lots. Forward a copy of the notification if you have provided the affected lot(s) outside of your facility. Post a copy of the notification by each VITROS System that processes VITROS HBsAg Controls and Complete and return the Confirmation of Receipt-Response Required form via fax to: 1.888.557.3759 or 1.585.453.4110 or scan to PDF and email to: RA-OCDUS-CONFIRMAD@ORTHOCLINICALDIAGNOSTICS.COM no later 7/1/2016. (Note: If you DO NOT have an alternate lot, it is acceptable to continue using the affected lot(s) following these instructions: 1) Control results must be within acceptable limits on the day of reconstitution (Day 1). 2) Store open-reconstituted vials frozen for up to 4 weeks. The firm recommends that customers aliquot the open-reconstituted material prior to freezing so that multiple aliquots of the same vial can be used. 3) Upon receipt of your replacement order, discard all remaining inventory.
Customers with questions please call the Ortho Technical Solutions Center at 1-800-421-3311.
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 investigation found the certain lots of mrsa kits have the potential for performance issues at lower positive sample concentrations.
Acción
Recall letters dated July 18, 2016 were sent to affected customers on July 19, 2016 by Federal Express. Letters advised users of the affected product and asked that any remaining inventory be destroyed.
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 product lot failed to meet qc acceptance criteria during stability testing. the calibrator od was dropping causing the positive control to be invalid (running high out of range).
Acción
Recall notification letters (dated 7/11/2016) were sent by FedEx on 7/11/2016. Customers were instructed to discontinue use of any remaining inventory (discard on site if any remaining). Customers were also advised that if the test resulted in a valid run, such that all Controls and Calibrator met the Quality Control Criteria as stated in the package insert, the patient results can be reported and a re-evaluation of patient results is not necessary. For questions, please contact Trinity Biotech's Help Desk at 1-800-325-3424 Option #3.
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
Immunochemical, Transferrin - Product Code JNM
Causa
R&d; systems, inc. received two customer complaints that results of the controls provided with the quantikine¿ ivd¿ human stfr immunoassay kit were out of the range high.
internal testing within r&d; systems confirmed a problem with control results being out of range high.
Acción
Consignees were sent via US mail on 8/24/2016 a R&D; systems "Urgent Medical Device Recall" letter dated August 23, 2016. The letter described the problem and the product involved in the recall. Advised consignees to stop using the kits and to discard all unused kits and complete and return the enclosed Acknowledgement and Receipt Form. For questions contact Bio-Technes Technical Service Department at 1-612-379-2956 or techserv@bio-techne.com.
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.
Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of rubella igm assay on the immmulite 2000/immulite 2000 xpi platforms.
Acción
Siemens sent an Urgent Medical Device Recall Letter IMC16-20.A.US , dated August 24, 2016, to the US consignees via FedEx, and an Urgent Field Safety Notice IMC16-20.A.OUS (dated August 2016) was sent to foreign representatives for distribution to foreign consignees. Customers were instructed to discontinue use of and discard the affected kit lots. Customers were also requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Recall letter within 30 days. Field service personnel will be sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. For questions, customers were instructed to contact their Siemens Customer Care Center or their local Siemens technical support 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.
Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of rubella igm assay on the immmulite 2000/immulite 2000 xpi platforms.
Acción
Siemens sent an Urgent Medical Device Recall Letter IMC16-20.A.US , dated August 24, 2016, to the US consignees via FedEx, and an Urgent Field Safety Notice IMC16-20.A.OUS (dated August 2016) was sent to foreign representatives for distribution to foreign consignees. Customers were instructed to discontinue use of and discard the affected kit lots. Customers were also requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Recall letter within 30 days. Field service personnel will be sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. For questions, customers were instructed to contact their Siemens Customer Care Center or their local Siemens technical support 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.
Multiple customers reported seeing an increase in imprecision with some patients resulting in high % cvs with the immulite 2000/2000xpi cmv (igm) assay starting with reagent lots 259 and above.
Acción
The firm, Siemens, issued an "Urgent Medical Device Recall" Letter (IMC16-22.A.US, dated 8/30/2016) in the US and an "Urgent Field Safety Notice" (IMC16-22.A.OUS, dated August 2016) Outside the US (OUS) starting on 8/30/2016 The notices instructed customers to discontinue use of and discard the affected kit lots listed in the customer notice; review your inventory of the products to determine your laboratory's replacement needs; review the UMDR and or the UFSN with their Medical Director, In the US, the method of distribution is FedEx and Outside the US the distribution is determined at the country level; complete and return the Field Correction Effectiveness Check Form via Fax to: Customer Care Center at (312) 275-7795 within 30 days, and retain this letter with your laboratory records, and forward this letter to those who may have received this product.
If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support 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.
Multiple customers reported seeing an increase in imprecision with some patients resulting in high % cvs with the immulite 2000/2000xpi cmv (igm) assay starting with reagent lots 259 and above.
Acción
The firm, Siemens, issued an "Urgent Medical Device Recall" Letter (IMC16-22.A.US, dated 8/30/2016) in the US and an "Urgent Field Safety Notice" (IMC16-22.A.OUS, dated August 2016) Outside the US (OUS) starting on 8/30/2016 The notices instructed customers to discontinue use of and discard the affected kit lots listed in the customer notice; review your inventory of the products to determine your laboratory's replacement needs; review the UMDR and or the UFSN with their Medical Director, In the US, the method of distribution is FedEx and Outside the US the distribution is determined at the country level; complete and return the Field Correction Effectiveness Check Form via Fax to: Customer Care Center at (312) 275-7795 within 30 days, and retain this letter with your laboratory records, and forward this letter to those who may have received this product.
If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support 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
Hepatitis Viral B DNA Detection - Product Code MKT
Causa
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an
analyzers sample rack tray. the cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
Acción
On 7/15/2016, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, an updated cleaning procedure, and instructions for responding to the formal recall notification. Please contact the Roche Support Network Customer Support Center at 1-800-428-2336 if you have questions about the information contained in this UMDC.
On 10/5/2016, URGENT MEDICAL DEVICE CORRECTION UPDATE notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The notification updated the 7/15/16 notification to include additional affected systems and to provide updated cleaning instructions for all systems via the enclosed Operators Manual addendum.
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.
Bd has determined that the bbl phoenixspec calibrator kits referenced in this recall from the following lots (5364776, 5345796 ) are labeled with an incorrect expiration date (year). the expiration date printed on the individual calibration tubes within the kit are correct but difficult to read on a portion of the tubes.
Acción
All US customers were contacted via letters sent via UPS. Ex-US BD sites will contact customers in their local regions. The firm will use an acknowledgement form included with the follow up letter that is mailed or faxed back to BD will be reconciled with the customer list. BD will contact 100% of our customers that have not responded to the communication to verify acknowledgement
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.
Bd has determined that the phoenixspec ap calibrator referenced in this recall from the following lot (5327782) are labeled with an incorrect expiration date (year). the expiration date printed on the individual calibration tubes within the kit are correct but difficult to read on a portion of the tubes.
Acción
All US customers were contacted via letters sent via UPS. Ex-US BD sites will contact customers in their local regions. The firm will use an acknowledgement form included with the follow up letter that is mailed or faxed back to BD will be reconciled with the customer list. BD will contact 100% of our customers that have not responded to the communication to verify acknowledgement
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
Antisera, all types, escherichia coli - Product Code GNA
Causa
Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.
Acción
On November 7, 2016 the firm sent Voluntary Medical Device Recall Letters and reply forms to their customers.
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
Cardiac c-reactive protein, antigen, antiserum, and control - Product Code NQD
Causa
Tina-quant cardiac c-reactive protein (latex) high sensitive (crphs) lot number 604450 (catalog number 11972855216) shows an under-recovery of up to -25% at concentrations below 5 mg/l on the modular analytics p module.
this issue can lead to erroneous low crphs results. crphs is used as a marker for the prediction of cardiovascular risk. an erroneous low result could lead to an incorrect cardiovascular risk assessment and subsequent delay of further examination.
Acción
Roche Diagnostics sent a Reagent Bulletin dated February 26, 2016, to all affected consignees. The recall notifications included a description of the reason for the recall, affected product, request for replacement, and consignee responsibilities; the notification did not include instructions for responding to the recall notification.
Actions Required
" Do not use CRPHS lot number 604450. If you have any affected product in your inventory, discard it per local guidelines.
" Complete the attached replacement request form to receive replacement product.
" File this Reagent Bulletin for future reference.
Questions
Please contact the Roche Support Network Customer Support Center at 1-800-428-2336 if you have questions about the information contained in this Reagent Bulletin.
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 lightcycler¿ 480 algorithm used for the lightmix¿ zika rrt-pcr test, eua (catalog number
07987897001) occasionally (~1% of the time) calls a positive result for a negative sample if there is
an inflection point in the fluorescence signal.
Acción
Roche Molecular Diagnostics Inc. sent an Urgent Medical Device Correction Letter dated November 16, 2016, to all affected customers via UPS. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use of the affected product until Roche provides updated Instructions for Use to assist in result interpretation. If product was further distributed, ensure the Urgent Medical Device Correction letter is provided to that site. Also, customers were instructed to completed the attached fax form and fax it to 1-888-912-2188. For questions customers should call 1-800-526-1247.
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
Total,prostate specific antigen(noncomplexed&complexed;) for detection of prostate cancer - Product Code MTF
Causa
Siemens healthcare diagnostics has confirmed that the immulite/ immulite 1000 systems psa assays are not meeting the current high-dose hook effect expectation in the instructions for use.
Acción
The firm, Siemens, sent an "Urgent Medical Device Correction Letter" (IMC 17-07.A.US, dated 11/2016) was sent via FedEx on 11/18/2016 to the US customers and an "Urgent Field Safety Notice" dated 11/2016 to customers outside the US (distribution is determined at the country level). The letter/notice described the product, problem and actions to be taken. Additionally, Field service personnel were sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. Customers were instructed to review letter with your medical doctor; review products and follow instructions; complete and return the attached Field Correction Effectiveness Check Form within 30 days by fax to Customer Care Center at (312) 275-7795; retain this letter with your laboratory records and forward this letter to those who may have received this product.
If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support 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
Total,prostate specific antigen(noncomplexed&complexed;) for detection of prostate cancer - Product Code MTF
Causa
Siemens healthcare diagnostics confirmed that the immulite 2000/ immulite 2000 xpi systems psa assays are not meeting the current high-dose hook effect expectation in the instructions for use.
Acción
The firm, Siemens, sent an "Urgent Medical Device Correction Letter" (IMC 17-07.A.US, dated 11/2016) was sent via FedEx on 11/18/2016 to the US customers and an "Urgent Field Safety Notice" dated 11/2016 to customers outside the US (distribution is determined at the country level). The letter/notice described the product, problem and actions to be taken. Additionally, Field service personnel were sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. Customers were instructed to review letter with your medical doctor; review products and follow instructions; complete and return the attached Field Correction Effectiveness Check Form within 30 days by fax to Customer Care Center at (312) 275-7795; retain this letter with your laboratory records and forward this letter to those who may have received this product.
If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support 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
Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System - Product Code PJI
Causa
Unique device identifier (udi) is missing from outer kit box label.
Acción
Customers were notified of the recall via email on December 5, 2016. Technical Support will ensure the customers receive the Recall Letter and understand the recommended actions. Customers were asked to retain this Medical Device Correction in your laboratory documentation until the affected lot inventory is either depleted or reaches expiration and to complete the enclosed response form and return it by fax to number 1-330-825-8520 (United States) /+358 2 2678 357 (outside United States) or as scanned by e-mail to TurkuQMresponse@perkinelmer.com as soon as possible, but not later than December 29, 2016.
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
Lambda, antigen, antiserum, control - Product Code DEH
Causa
Batch numbers listed are reporting lambda free light chain results >114mg/l that are on average 33% lower than other optilite lambda freelite batches. therefore users moving to this batch will see results >114mg/l giving lower results and conversely when switching to the next batch results will be seen to shift upwards.
Acción
On 07/05/16 notification letters were sent to customers.
The Binding Site Group requests the following:
- Immediately Quarantine & Dispose of any LK018.OPT lot 405566 kits within stock;
- Remove any affected lots from the Optilite instrument;
- Patients with Lambda Freelite results >114mg/L should be reviewed in consultation with clinicians, alongside other clinical findings and retested where applicable;
- Notify local Binding Site representative to request replacement kits;
- Return completed E-Back Form to local Binding Site Representative;
The firm recommended that the notice be circulated to those within the organization who need to be aware.
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
Lambda, antigen, antiserum, control - Product Code DEH
Causa
Calibration curve activity has increased over time in the kit lots listed.
Acción
Customer notification letters were sent 11/28/12. Customers were asked to discontinue using the listed kit lots. Discard any unused or partially-used kits of these lots. Let The Binding Site know how many replacement kits are required.
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
Gram-positive bacteria and their resistance markers - Product Code PAM
Causa
The great basin staph id/r panel is being recalled because the s. aureus probe could potentially result in a false positive.
Acción
The firm, Great Basin Scientific, notified customers by phone beginning on December 12, 2016 and by email on December 14 and 15, 2016. The notifications described the product, problem and actions to be taken. The customers were instructed to cease using and immediately discard all affected cartridges, the firm will replace those cartridges as soon as possible; and respond to the email or call Direct: 385.219.4540 or Support Team 888.333.9763 or email: customerssupport@gbscience.com with any questions or concerns.
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
Total,prostate specific antigen(noncomplexed&complexed;) for detection of prostate cancer - Product Code MTF
Causa
Negative bias with immulite¿ /immulite¿ 1000 third generation psa (prostate-specific antigen) kit. the investigation by siemens has confirmed that patient samples exhibit an average negative bias of approximately -22% with a range of -16% to -27% for samples recovering from 0.08 to 16.2 ng/ml.
Acción
Siemens issued an Urgent Medical Device Recall Notice letter dated December 21, 2016, to their U.S.A customers via Fed Ex and an Urgent Field Safety Notice letter dated December 2016, to customers outside the US (OUS). The notices instruct customers to discontinue use of and discard the affected kit lots listed in Table 1 of the customer communication. Customers are requested to review the UMDR and or the UFSN with their Medical Director. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Recall letter within 30 days. U.S.A customers are advised to fax the Effectiveness Check questionnaire to (312) 275-7795. Field service personnel will be sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. Customers with questions should contact their local Siemens technical support 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
Total,prostate specific antigen(noncomplexed&complexed;) for detection of prostate cancer - Product Code MTF
Causa
Negative bias results with the immulite¿ /immulite¿ 1000 third generation psa (prostate-specific antigen) kit was confirmed for two lots (d0119 and d0120). the investigation by siemens has confirmed that patient samples exhibit an average negative bias of approximately -22% with a range of -16% to -27% for samples recovering from 0.08 to 16.2 ng/ml.
Acción
Siemens issued an Urgent Medical Device Recall Notice letter dated December 21, 2016, to their U.S.A customers via Fed Ex and an Urgent Field Safety Notice letter dated December 2016, to customers outside the US (OUS). The notices instruct customers to discontinue use of and discard the affected kit lots listed in Table 1 of the customer communication. Customers are requested to review the UMDR and or the UFSN with their Medical Director. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Recall letter within 30 days. U.S.A customers are advised to fax the Effectiveness Check questionnaire to (312) 275-7795. Field service personnel will be sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. Customers with questions should contact their local Siemens technical support 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
Method, nephelometric, immunoglobulins (g, a, m) - Product Code CFN
Causa
A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert.
Acción
Customer notification letters were sent on 12/23/16.
The Binding Site recommends to continue testing on the kit as normal and refer to the measuring ranges and limit of quantification stated in the notice and as indicated in the amended insert (INS009.OPT.A, Version: 21st December 2016) provided with this notification.
The notice needs to be passed on to all those who need to be aware within the organization or to any Organization where the potentially affected devices have been transferred.
Return the completed E-Back Form to your local Binding Site Representative for records and note that The Binding Site intends to report this correction to the FDA recall coordinator.
If you have any questions contact Technical Services.
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
Data acquisition software - Product Code PQQ
Causa
Power outages causes reporting software to shutdown.
Acción
Tosoh Bioscience sent a Customer Recall Notification letter dated December 21, 2016 to customers. The letter identified the affected product, problem and action to be taken. For questions call Tosoh Technical Support at 800-248-6764.