Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Notas adicionales en la data
Recalling Organisation: Medi'Ray New Zealand Ltd, 53-55 Paul Matthews Road, Albany, Auckland 0632
Causa
Following receipt of customer complaints, the manufacturer has determined that selected lots of this test have shifted in performance when compared to the published performance characteristics.
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.
During an investigation of instrument logs it was determined that in specific circumstances involving multiple steps, a rack sequencing error may occur. this will result in a mismatch between the sample id and the test result reported for all subsequent sample racks in that run.
Acción
ThermoFisher sent an Urgent Medical Device Product Correction letter to all affected customers. The firm will inform customers of the specific sequence of errors and operator actions that can trigger the event via letter and phone, and will request that they do not respond to the Barcode Read Error and let the sample with the error eject normally from the instrument and be rerun after the barcode read error has been resolved. The firm will issue a mandatory Phadia 1000 Instrument Software (ISW) update that will correct the issue and make efforts to install it within 45 days from date of availability. Customers were asked to return the written response form via fax to: 1-888-243-5214
Attention: Customer Support, Phadia 1000 ISW Product Correction Response; EMAIL: Compliance-us.idd@thermofisher.com
Email Subject Line: Phadia 1000 ISW Product Correction Response.
Customers with questions were instructed to contact Phadia US Technical Support at 800-346-4364, option 2.
For questions regarding this recall call269-492-1957.
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.
Through in-house routine real time stability monitoring of trinity's captia syphilis igm capture test kit, lot 033, the firm identified a failure of the kit to meet its labeled expiry dating of 6 months.
Acción
Recall notification letters were sent by e-mail to 2 US customers on 11/17/2014 and 11/19/2014. The remaining US customers were sent the letter by FedEx on 11/19/2014. Customers are instructed to discontinue use of any remaining inventory (discard on site if any remain) and provide date of last use (run) and if they obtained valid or invalid runs. Additionally, Trinity is in the process of sending the recall letters to the required EU Regulatory Authorities and the 3 foreign distributors.
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
Somatic gene mutation detection system - Product Code OWD
Causa
Cobas kras mutation kit t10786 is generating invalid results for the mutant control and/or kras calibrator.
Acción
RMS issued an Urgent Field Safety Notice on 12/18/2014.
A Quality Notification was provided to all users of the of cobas¿ KRAS Mutation Kit CE-IVD, lots T13091, T15435, T15475, T14777, and W00389, informing them of the issue and instructing them to discontinue use and discard any remaining inventory immediately.
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
Reagent, immunoassay, igg - Product Code KTO
Causa
The firm is recalling three batches (fp14a09, fp14a10, fp14a11) of spermmar iga test due to new formulation causing the motility of sperm cells to reduce in certain samples when the new bead solution was added.
Acción
FertiPro sent an Urgent: Medical Device Recall letter dated December 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The customers were instructed to check if they have stock of the concerned lots and provide a confirmation that they have destroyed the affected products.
Distributors were asked to inform their customers and instruct them to do the same.
For further questions you may call (858) 824-0888.
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
Culture media, selective and differential - Product Code JSI
Causa
The firm is recalling hardychrom ss, cat. no. g327 lot no. 15037 due to a report of possible lack of color development in shigella organisms in the referenced lot.
Acción
On 03/12/2015 the firm sent recall notification letters to customers.
The firm's letter informs customers of the reason for recall, and requests that they discard any remaining stock of the recalled lot.
The firm continues to request that even though the customer has been informed of the necessary actions that they still take a moment to complete, sign, and fax back the enclosed form stating their compliance with the above action to the attention of their Quality Assurance Department at (805) 614-9274. The firm stated that the form is required for their records and need to document the full quantity received, used and/or discarded.
For replacements or credit to please contact the Customer Service Department at (800) 266-2222 and select option 1. The firm states that replacements will be sent out at no charge to customers, or a credit will be applied to the invoice.
For any additional questions the firm states to contact Technical Services at (800) 266-2222, option 2 or e-mail at techservice@hardydiagnostics.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.
Focus diagnostics is recalling the stratify jcv dx select due to the use of a non-conforming batch in the manufacture of jcv dxselect el1950 kit lot #27333. this could lead to a potential for false positive jcv results.
Acción
Focus Diagnostics sent an Urgent Device Customer Notification letter dated March 15, 2015, was sent to the customer to inform them that Focus Diagnostics is recalling the Stratify JCV DxSelect (EL1950) lot#27333 due to the potential for false positive JCV results. The letter informs the customer of the issues and the actions to be taken. The customer is instructed to complete the enclosed acknowledgement form and email the form to DxTS@focusdx.com or fax back to Focus Diagnostics Technical Services at (562) 240-6526 within 10 business days.
If the customer has any questions or require additional information, then they are instructed to contact Focus Diagnostic's Technical Services department at (800) 838-4548, select option 3, between the hours of 7am to 5pm (PST) or send an email to DxTS@focusdx.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.
Notas adicionales en la data
Susceptibility test cards, antimicrobial - Product Code LTW
Causa
The test kits have out-of-range-low (oorl) flucytosine qc results for candida krusei atcc 6258.
Acción
The notification, consisting of the Field Safety Corrective Action (FSCA #2488) packet, was issued electronically to the subsidiaries and distributors on 3/27/15. FSCA #2509 was issued electronically to the subsidiaries and distributor on 4/13/15, which superseded FSCA #2488.
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
Susceptibility test cards, antimicrobial - Product Code LTW
Causa
The test kits have out-of-range-low (oorl) flucytosine qc results for candida krusei atcc 6258.
Acción
The notification, consisting of the Field Safety Corrective Action (FSCA #2488) packet, was issued electronically to the subsidiaries and distributors on 3/27/15. FSCA #2509 was issued electronically to the subsidiaries and distributor on 4/13/15, which superseded FSCA #2488.
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
Susceptibility test cards, antimicrobial - Product Code LTW
Causa
The test kits have out-of-range-low (oorl) flucytosine qc results for candida krusei atcc 6258.
Acción
The notification, consisting of the Field Safety Corrective Action (FSCA #2488) packet, was issued electronically to the subsidiaries and distributors on 3/27/15. FSCA #2509 was issued electronically to the subsidiaries and distributor on 4/13/15, which superseded FSCA #2488.
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
Manual antimicrobial susceptibility test systems - Product Code JWY
Causa
Siemens healthcare diagnostics has received complaints regarding panel degradation with a portion of the microscan neg breakpoint combo 34 (nbp34) panel lot 2014-05-28.
Acción
Siemens sent an Urgent Medical Device Recall letter dated May 14, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The risk to health is explained and users are asked to discontinue use and discard any of the recalled lot still in inventory. No other lot numbers of the NBPC 34 panels are affected and may still be used. The Field Correction Effectiveness Check form should have been completed and returned to Siemens.
PLEASE FAX THIS COMPLETED FORM TO 302-631-8467.
Contact Siemens Customer Care Center or local Siemens Tech support.
For further questions please call (916) 374-3031
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
Somatic gene mutation detection system - Product Code OWD
Causa
False positive results for exon 20 insertion mutations are being detected with the cobas¿ egfr mutation
test, kit batch t08661.
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
Complaints have been confirmed on failed proficiency testing due to serum samples recovering too low when using some n latex igm reagent kit lots 44018, 44019 and 44042.
Acción
The firm, Siemens, sent an "Urgent Medical Device Recall" letter dated January 2015 to its customers on January 13, 2015. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Discontinue use of the affected lots and discard any remaining material; Identify if IgM quotient was overestimated due to falsely low IgM results with serum sample; Reconsider patient diagnosis taking other patient data into consideration.; When other patient data does not support the result for an intrathecal IgM synthesis or inflammation, re-measurement of samples may be considered using and alternative lot. In addition, Siemens requested customers to review this letter with their Medical Director; to complete and return the attached Effectiveness Check/Product Replacement form via 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 800-441-9250 or email: aydee.I.crawford@siemens.com 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
Supplement, culture media - Product Code JSK
Causa
Use of the product may not provide adequate recovery and could result in false negative identification of legionella pneumophila.
Acción
ThermoFisher Scientific sent an Urgent Medical Device Recall letter dated February 5, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The letter informed the consignees of the recall and the associated risk of false negative identification of Legionella pneumophila. The consignees were instructed to notify any personnel who need to be aware of the potential for false negative id. of Legionella spp. Further, the consignees were instructed to discard any affected product remaining in their inventory and review all results reported using the recalled lot. The recalling firm requested the consignees complete and return the Medical Device Recall Return Response form acknowledging receipt of the notice and disposal of the affected product. If the affected lot was further distributed, the consignees were instructed to notify those entities of the recall and provide a copy of the recall notification letter.
If you have any questions, please contact our Technical Services Department at 800.255.6730 (US) or 913.888.0939 ( International)
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
Susceptibility test cards, antimicrobial - Product Code LTW
Causa
The outer carton label and package insert for the recalled product incorrectly lists streptococcus pneumoniae as an organism for intended use.
Acción
Biomerieux, Incs sent an Urgent Product Correction Notice on February 25, 2015, to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. Customers were instructed to do the following:
" Please confirm this letter has been distributed and reviewed by all appropriate personnel within your
organization.
" For the referenced test kits (VITEK¿ 2 ASTP635, ASTP640 or ASTP641), review the claimed organisms in
the Package Insert antibiotic table to confirm which organisms can be tested.
" Refrain from using the referenced test kits to determine the susceptibility of Streptococcus pneumoniae.
" Reference your Laboratory Standard Operating Procedures to identify card type used for specific organisms.
" Please store this letter with your bioM¿rieux instrument documentation.
Please complete the attached Acknowledgement Form and return it to bioM¿rieux, Inc.
Customers with questions were instructed to contact their local BioMerieux representative.
For questions regarding this recall call 314-731-8526.
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
Susceptibility test cards, antimicrobial - Product Code LTW
Causa
The outer carton label and package insert for the recalled product incorrectly lists streptococcus pneumoniae as an organism for intended use.
Acción
Biomerieux, Incs sent an Urgent Product Correction Notice on February 25, 2015, to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. Customers were instructed to do the following:
" Please confirm this letter has been distributed and reviewed by all appropriate personnel within your
organization.
" For the referenced test kits (VITEK¿ 2 ASTP635, ASTP640 or ASTP641), review the claimed organisms in
the Package Insert antibiotic table to confirm which organisms can be tested.
" Refrain from using the referenced test kits to determine the susceptibility of Streptococcus pneumoniae.
" Reference your Laboratory Standard Operating Procedures to identify card type used for specific organisms.
" Please store this letter with your bioM¿rieux instrument documentation.
Please complete the attached Acknowledgement Form and return it to bioM¿rieux, Inc.
Customers with questions were instructed to contact their local BioMerieux representative.
For questions regarding this recall call 314-731-8526.
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
Susceptibility test cards, antimicrobial - Product Code LTW
Causa
The outer carton label and package insert for the recalled product incorrectly lists streptococcus pneumoniae as an organism for intended use.
Acción
Biomerieux, Incs sent an Urgent Product Correction Notice on February 25, 2015, to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. Customers were instructed to do the following:
" Please confirm this letter has been distributed and reviewed by all appropriate personnel within your
organization.
" For the referenced test kits (VITEK¿ 2 ASTP635, ASTP640 or ASTP641), review the claimed organisms in
the Package Insert antibiotic table to confirm which organisms can be tested.
" Refrain from using the referenced test kits to determine the susceptibility of Streptococcus pneumoniae.
" Reference your Laboratory Standard Operating Procedures to identify card type used for specific organisms.
" Please store this letter with your bioM¿rieux instrument documentation.
Please complete the attached Acknowledgement Form and return it to bioM¿rieux, Inc.
Customers with questions were instructed to contact their local BioMerieux representative.
For questions regarding this recall call 314-731-8526.
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, blood culturing - Product Code MDB
Causa
Use of the recalled product may result in false positive reports.
Acción
Remel, Inc. a part of Thermo Scientific sent a Product Correction Notification dated May 19, 2015, to all affected customers. The notification states the problem with the device and that the recalling firm's Technical Services department will be contacting the customer to schedule a field service of the device to correct the issue. Customers were instructed to notify any personnel who need to be notified of the potential for a false positive resulting from rare inconsistent barometric pressure readings. Return the attached Medical Device Recall Return Response form acknowledging receipt of the notice of the affected product. If product was further distributed customers were instructed to contact those entities, advise them of the situation and provide them with a copy of the letter. Customers with questions were instructed to contact the Technical Services Department at 800-642-7029. For questions regarding this recall call 770-409-0713.
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
Manual antimicrobial susceptibility test systems - Product Code JWY
Causa
Qc results were out of range resulting in false resistant strains.
Acción
BioMerieux sent an Urgent Product Removal Notices dated June 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Required actions:
¿¿ Please distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product.
¿¿ Discontinue using and discard any remaining inventory of Etest¿¿ CEFOTAXIME CT 256 lots reported in table 1.
¿¿ Discuss any concerns you may have regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action.
¿¿ Complete and return the Acknowledgement Form in Attachment A by Fax to confirm receipt of this notice and to request product replacement.
bioM¿¿rieux is committed to providing our customers with the highest quality product possible. We sincerely apologize for any inconvenience that this may have caused you. If you require additional assistance or have any questions, please contact your local bioM¿¿rieux Clinical Customer Service organization at (800) 682-2666.
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.
Hardy diagnostics is recalling hardychrom vre agar due to lack of 510(k) clearance.
Acción
The firm initially called customers to inform them of the recall. The firm's phone script stated that they were discontinuing the product and as part of the process were recalling anything that still might be within expiration date. The phone script stated that the firm was going to be sending something in writing.
On 06/24/15 the firm sent out a notification letters to customers to inform them that they were discontinuing the product, and were requested anything remaining within expiration to be discarded. The firm requests that customers complete, sign, and fax back the enclosed form stating their compliance with the above action.
For any questions the firm states to contact Technical Services Department at 800-266-222, option 2 or via email at TechService@HardyDiagnostics.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.
Notas adicionales en la data
Culture media, non-selective and non-differential - Product Code JSG
Causa
Product may be contaminated with listeria monocytogenes.
Acción
The recalling firm sent the recall notification letter (dated May 1, 2015) to all customers on 5/4/2015 via standard mail.
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, blood culturing - Product Code MDB
Causa
Use of the recalled product may result in false positive reports.
Acción
Remel, Inc. a part of Thermo Scientific sent a Product Correction Notification dated May 19, 2015, to all affected customers. The notification states the problem with the device and that the recalling firm's Technical Services department will be contacting the customer to schedule a field service of the device to correct the issue. Customers were instructed to notify any personnel who need to be notified of the potential for a false positive resulting from rare inconsistent barometric pressure readings. Return the attached Medical Device Recall Return Response form acknowledging receipt of the notice of the affected product. If product was further distributed customers were instructed to contact those entities, advise them of the situation and provide them with a copy of the letter. Customers with questions were instructed to contact the Technical Services Department at 800-642-7029. For questions regarding this recall call 770-409-0713.
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.
Immulite 2000/2000xpi italian cypress (t23l4), lots 206 and 208, fail to meet specifications to support the shelf-life stability of 2 years (24 months) expiration date as indicated on the products label.
Acción
Siemens Healthcare Diagnostics issued an Urgent Medical Device Recall Letter (IMC-15-11A.US, dated May 6, 2015) in the US via FedEx, and an Urgent Field Safety Notice (IMC-15-11A.OUS, May 2015) outside the US on May 6, 2015. Customers were instructed to immediately discontinue use of and discard IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen, lot 206. The shelf-life of IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen, lot 208, has been shortened to June 30, 2015. Discontinue use and discard lot 208 after June 30, 2015. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Recall letter within 30 days in the US and OUS and fax to Customer Care Center at 312-275-7795.
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.
Due to a supplier issue, the incorrect green and amber led components were used in the manufacture of the led printed circuit board assemblies (pcba) in certain cobas liat analyzers.
Acción
Roche sent an Urgent Medical Device Recall letter dated July 24, 2015, to all affected customers. The letter identified the product the problem and the action to be taken by the customer.
Actions Required
Identify the affected systems in your inventory by referencing the serial numbers in the table on page 1.
You will be contacted to return affected systems for immediate replacement.
Complete the attached fax form and fax it to 1-317-521-4815.
File this UMDR for future reference.
Please contact the Roche Support Network Customer Support Center cobas¿ Liat hotline at 1-800-800-5973, 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.
Hardy diagnostics is recalling hardychrom mrsa due to a report of the potential for breakthrough of the methicillin-sensitive staphylococcus aureus (mssa) qc strain, atcc 29213 on the identified lot.
Acción
The firm initially notified customers via phone to inform them of a recall. The phone scripts asks customers if they have had any issued with the QC testing. The firm states that our of a precaution they are asking customers to discard the remaining plates of the identified lot, and that credit or replacement plates will be offered for any remaining.
The firm followed-up phone calls with a written notification letter. The letter states to complete, sign, and fax or email back the enclosed form stating compliance with the above action. The letters states that is the customer could not be reached via phone and would like replacements or credit to contact the Customer Service Department at 800-266-2222, option 1.
Any questions call the Technical Services Department at 800-266-2222, option 2 or email at techservice@hardy diagnostics.com.