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.
Product labels indicate that the products are for ivd use and they do not have an approved 510(k).
Acción
The firm, BioCheck, sent an "URGENT: DEVICE RECALL" letter dated December 22, 2010 to all customers. The letter described the product, problem and actions to be taken by customers. The customer were instructed to examine their inventory for the affected lots, if found, discontinue distributing the lots and promptly return via Fedex to BioCheck at 323 Vintage Park Drive, Foster City, CA 94404, Attn: RETURNED GOODS; immediately contact their accounts, if they further distributed the product, and inform them of the Recall, and complete and return the response form via email at: info@biocheck.com or fax to (650-573-1969) immediately.
If you have any questions, please call (650) -573-1968 anytime during office hours (8:30am to 5:30pm Pacific time).
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.
Product labels indicate that the products are for ivd use and they do not have an approved 510(k).
Acción
The firm, BioCheck, sent an "URGENT: DEVICE RECALL" letter dated December 22, 2010 to all customers. The letter described the product, problem and actions to be taken by customers. The customer were instructed to examine their inventory for the affected lots, if found, discontinue distributing the lots and promptly return via Fedex to BioCheck at 323 Vintage Park Drive, Foster City, CA 94404, Attn: RETURNED GOODS; immediately contact their accounts, if they further distributed the product, and inform them of the Recall, and complete and return the response form via email at: info@biocheck.com or fax to (650-573-1969) immediately.
If you have any questions, please call (650) -573-1968 anytime during office hours (8:30am to 5:30pm Pacific time).
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
There is an issue regarding liquid level detection of the cs1 magnetic glass particles (mgp) reagent cassette of the cobas ampliprep /cobas taqman hbv v2.0 test on the cobas ampliprep instrument.
Acción
Roche sent Urgent Medical Device Correction Letters to their consignees on December 28, 2010 via Fed Ex. The letters advise the customers to verify the correct configuration of the CSI reagent cassette, remind customers to follow the package insert instructions for including all required controls for each batch and advise that review of previously generated results may be warranted. A UMDC Faxback form was attached for the consignee to complete.
For questions regarding this recall call 908-253-7569.
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
Test, hepatitis b (b core, be antigen, be antibody, b core igm) - Product Code LOM
Causa
Through internal testing, diasorin has become aware that the kit lots identified (eti-ab-auk plus kits, catalog number p001931, lot numbers 0650270a and/or 0650270a/1) may not consistently exhibit stability to defined expiration dating, resulting in decreased binding and lower absorbance. internal testing has confirmed that when defined assay validation criteria pass, analytical performance is co.
Acción
The firm, DiaSorin, sent a "Customer Notification Letter" dated 19 August, 2010 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to destroy all remaining inventory and complete and return the receipt of notification and destruction of product form, found in the bottom portion of the letter, via fax to: (651) 351-5669, ATTN: TECHNICAL SERVICES or mail to: ATTN: TECHNICAL SERVICES, 1951 Northwestern Ave., Stillwater, Minnesota 55082-0285.
If you have any questions or concerns, please contact DiaSorin Inc., Technical Services at 1-800-328-1482 or 651-439-9710.
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
Epstein-barr virus, other - Product Code LSE
Causa
Bio-rad laboratories confirmed a downward shift in control values for ebv na-1 analyte when using the bioplex 2200 ebv igg calibrator set lot #46704.
Acción
The firm, Bio-Rad Laboratories, sent an "Voluntary Field Correction: BioPlex 2200 EBV IgG Calibrator Set, Lot# 46704 for EBV NA-1 Analyte" letter dated March 16, 2011 domestic customers via Fed-Ex and and to international subsidiaries via e-mail. The letter described the product, problem and actions to be taken. The consignees/customers were informed that Bio-Rad confirmed downward shift in control values for the EBV NA-1 analyte when using the BioPlex 2200 EBV IgG Calibrator Set, Lot # 46704. If this occurs, the customers were instructed to readjust the positive control mean using the procedure presented in the customer notification "BioPlex 2200 Quality Control Values (L60013402)". If the re-adjusted mean of the EBV NA-1 controls is within the manufacturer's limit, patient results may be reported.
If the new assay positive control mean still does not fall within the manufacturer's limit, the customers were instructed to contact their local Bio-Rad Technical Support and do not report the EBV NA-1 values. The customers were also instructed to complete and return the CUSTOMER RESPONSE FORM via fax to 510-741-5775.
If the BioPlex 2200 EBV VCA IgG and EBV EA-D IgG positive and negative control means are within the acceptable QC range, and subsequent passing QC runs are obtained, patient results may be reported for these analytes.
Bio-Rad will be manufacturing a new lot of the BioPlex 2200 EBV IgG Calibrator Set which will bring the control values within the manufacturer's limit. It may be necessary to readjust the QC ranges after the consignees receive this new calibrator set lot.
Bio-Rad will send their consignees/customers the replacement calibrators and calibrator CDs when available.
The consignees/customers were also instructed to discard the calibrator set lot# 46704 in accordance with national and/or local regulations.
Customers can call Clinical Diagnostics Group at 510-741-4431 or email to BPD-ProductSupport@bio-rad.com for any questions
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 powers, antimycobacterial - Product Code MJA
Causa
In vitro diagnostic device components are mislabeled.
Acción
BD Diagnostic Systems sent an Urgent Product Recall letter on August 31, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter advised customers to discard any carriers or labels that contain the incorrect barcode for replacement.
Accounts were requested to complete an attached reply form to acknowledge their receipt of the notification and fax it to 410-316-4258.
For questions regarding this recall call BD Customer Service at 1-800-675-0908.
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 powers, antimycobacterial - Product Code MJA
Causa
In vitro diagnostic device components are mislabeled.
Acción
BD Diagnostic Systems sent an Urgent Product Recall letter on August 31, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter advised customers to discard any carriers or labels that contain the incorrect barcode for replacement.
Accounts were requested to complete an attached reply form to acknowledge their receipt of the notification and fax it to 410-316-4258.
For questions regarding this recall call BD Customer Service at 1-800-675-0908.
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 powers, antimycobacterial - Product Code MJA
Causa
In vitro diagnostic device components are mislabeled.
Acción
BD Diagnostic Systems sent an Urgent Product Recall letter on August 31, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter advised customers to discard any carriers or labels that contain the incorrect barcode for replacement.
Accounts were requested to complete an attached reply form to acknowledge their receipt of the notification and fax it to 410-316-4258.
For questions regarding this recall call BD Customer Service at 1-800-675-0908.
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
Test,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign condit - Product Code MTG
Causa
A recall was initiated because beckman coulter has confirmed a change to the recommended diluents for the access hybritech free psa reagent.
Acción
Beckman Coulter sent a Product Correction letter dated October 11, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed regarding a change to the recommended diluents for the Access Hybritech free PSA reagent. Patient safety is not affected by this change.
" Do not dilute elevated free PSA patient samples with Wash Buffer II.
" Do not dilute elevated free PSA patient samples using the UniCel DxI onboard dilution feature.
" Dilute elevated free PSA samples with Access Hybritech free PSA Calibrator S0 only.
" A review of historical patient results is not required because there is no effect on clinical interpretation.
* The UniCel DxI onboard dilution feature is only available in limited geographies.
" An updated version of the UniCel DxI Assay Protocol File (APF) will remove the Access Hybritech free PSA (dfPSA) onboard dilution assay from the list of available assays.
" The Access Hybritech free PSA IFU will be updated to remove Wash Buffer II as an acceptable diluent for elevated patient samples. Correct any procedure manuals or other documents created in your laboratory that list Wash Buffer II as an acceptable diluent for the Access Hybritech free PSA assay.
Please share this information with your laboratory staff. If you have forwarded any of the affected product listed above to another laboratory, please provide a copy of the letter to them.
Please complete and return the enclosed response form within 10 days so we are certain you received this important communication.
If you have any questions regarding this notification, please contact our Customer Support Center
" Via our website, http://www.beckmancoulter.com/customersupport/support
" Via phone, call 1-800-854-3633 in the United States and Canada
Outside the United States and Canada, contact your local Beckman Coulter Representative. We apologize for the inconvenie
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, immunological, antigen, tumor - Product Code MOI
Causa
Br assay for ca 27.29 calibration interval change due quality control (qc) results outside of the expected ranges.
Acción
Siemens sent two "URGENT FIELD SAFETY NOTICE" letters dated August and September 2012 to all affected customers. The letters identified the product, problem, and actions to be taken by the customers. A Field Correction Effectiveness Check Form was included for customers to complete and return.
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
Nucleic acid amplification assay system, group b streptococcus, direct specimen test - Product Code NJR
Causa
Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results.
Acción
Becton Dickinson sent an Urgent Field Corrective Action letter September 18, 2012,by fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that BD Field Service Associates will contact them within 7-10 days of the notification to determine if their instrument is impacted. Customers were requested to return a response form indicating the serial number on their instrument. If customers needed further assistance they were instrycted ti contact BD Technical Services Department at 1-800-638-8663.
For questions regarding this recall call 410-316-4054.
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
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Acción
BIOMERIEUX sent an Urgent Product Correction Notice to all affected customers starting on October 16, 2012, The letter identified the affected product, the problem, and the action to be taken by hte customer. The firm provided modified instructions for use to clarify how to properly load bottles and to provide appropriate cautions and warnings concerning bottle loading. Customers were instructed to ensure that the letter and guidance on how to properly scan and load bottles is distributed, and training is provided to all appropriate personnel within their organization. Check for lost bottles in their system; fill out and return the Acknowledgement Form in Attachment A by fax to confirm receipt of the notice. Customers were instructed to contact their local bioMerieux Customers Service Representative with any questions.
For questions regarding this recall call 919-620-2682.
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
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Acción
BIOMERIEUX sent an Urgent Product Correction Notice to all affected customers starting on October 16, 2012, The letter identified the affected product, the problem, and the action to be taken by hte customer. The firm provided modified instructions for use to clarify how to properly load bottles and to provide appropriate cautions and warnings concerning bottle loading. Customers were instructed to ensure that the letter and guidance on how to properly scan and load bottles is distributed, and training is provided to all appropriate personnel within their organization. Check for lost bottles in their system; fill out and return the Acknowledgement Form in Attachment A by fax to confirm receipt of the notice. Customers were instructed to contact their local bioMerieux Customers Service Representative with any questions.
For questions regarding this recall call 919-620-2682.
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
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Acción
BIOMERIEUX sent an Urgent Product Correction Notice to all affected customers starting on October 16, 2012, The letter identified the affected product, the problem, and the action to be taken by hte customer. The firm provided modified instructions for use to clarify how to properly load bottles and to provide appropriate cautions and warnings concerning bottle loading. Customers were instructed to ensure that the letter and guidance on how to properly scan and load bottles is distributed, and training is provided to all appropriate personnel within their organization. Check for lost bottles in their system; fill out and return the Acknowledgement Form in Attachment A by fax to confirm receipt of the notice. Customers were instructed to contact their local bioMerieux Customers Service Representative with any questions.
For questions regarding this recall call 919-620-2682.
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
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Acción
BIOMERIEUX sent an Urgent Product Correction Notice to all affected customers starting on October 16, 2012, The letter identified the affected product, the problem, and the action to be taken by hte customer. The firm provided modified instructions for use to clarify how to properly load bottles and to provide appropriate cautions and warnings concerning bottle loading. Customers were instructed to ensure that the letter and guidance on how to properly scan and load bottles is distributed, and training is provided to all appropriate personnel within their organization. Check for lost bottles in their system; fill out and return the Acknowledgement Form in Attachment A by fax to confirm receipt of the notice. Customers were instructed to contact their local bioMerieux Customers Service Representative with any questions.
For questions regarding this recall call 919-620-2682.
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
The product may contain low level microbial contamination which could result in incorrect results.
Acción
ThermoFisher Scientific notified customers on October 10, 2012, with a Field Safety Notice letter to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were advised use of this lot could result in incorrect results reporting. This notice needs to be passed on to all who need to be aware within your organization.
The firm request the information form be faxed back confirming receipt of notice.
For further information please contact Technical Support via our main switchboard on +44 (0) 1256 841144.
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, fluorescent, all types, hemophilus spp. - Product Code GRO
Causa
In vitro diagnostic test kit was not manufactured according to specifications and may cause false negatives or misidentification of hemophilus species present in patient specimens.
Acción
BD Diagnostic Systems sent an Urgent Product Recall letter dated October 22, 2012, to all affected customers.. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to discontinue distribution and discard affected inventory for credit. . Customers were requested to return a response form by fax to 410-316-4258. For questions customers were instructed to contact BD Customer Service Department at 1-800-638-8663. For assistance with replacements, customers were instructed to call 1-800-675-0908.
For questions regarding this recall call 410-316-4258.
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
Micro total analysis instrument system - Product Code OUE
Causa
The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. as a result, the lift arm fell down approx. 60 cm (23.6 inches).
Acción
A Medical Device Correction letter, dated September 11, 2013, was sent to all direct accounts. The letters advised customers that a Leica Microsystems representative will contact them and make arrangements to conduct an inspection of the ceiling mount(s) and to provide additional preventative maintenance and inspection protocols for the devices. Customers are asked to complete and return the enclosed Acknowledgement Form and send it back to Leica Microsystems within 10 days of receiving the Medical Device Correction letter. Customers with questions should contact their Leica Microsystems 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
Micro total analysis instrument system - Product Code OUE
Causa
The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. as a result, the lift arm fell down approx. 60 cm (23.6 inches).
Acción
A Medical Device Correction letter, dated September 11, 2013, was sent to all direct accounts. The letters advised customers that a Leica Microsystems representative will contact them and make arrangements to conduct an inspection of the ceiling mount(s) and to provide additional preventative maintenance and inspection protocols for the devices. Customers are asked to complete and return the enclosed Acknowledgement Form and send it back to Leica Microsystems within 10 days of receiving the Medical Device Correction letter. Customers with questions should contact their Leica Microsystems 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.
Sekisuki diagnostics has issued a product correction for certain lot numbers of the osom c. difficile toxin a/b test kit, because it has been determined that there is potential for false negative results.
Acción
Sekisui Diagnostic sent an Customer Recall Notification letter dated September 16, 2013, via email and/or FedEx. The letter identified the product the problem and the action needed to be taken by the customer.
The customer notification letter informs the customers that Sekisui Diagnostics has issued a Product Correction for certain lots of the OSOM C. difficile Toxin A/B Test Kit (P/N 173). The customer notification lists the reason for recall, instructions to the customer, product description, required actions, and contact information. Customer Notification Letter lists the specific lot numbers being recalled for that catalog number. For each of these two catalog numbers, there is one letter directed to a distributor and one letter directed to an end user. Customer letters will be sent by email and/or FedEx. The letters have REQUIRED ACTIONS outlined in a box. If no response is received within 30 days, there will be directed follow-up communication.
For further questions please call ( 858) 777-2600.
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
An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated diagnostic instrument may cause a false negative result.
Acción
BD sent an Urgent Product Recall letter dated September 2013 to customers identified as microbiology lab managers. The letter identified the affected product, problem and actions to be taken. The letter advised that referenced lot numbers may contain an overlabel barcode that may begin to lift, exposing the original incorrect barcode pictured in the notification. Customers were instructed to complete the attached form and fax to Regulatory Compliance 410-316-4258. For further assistance regarding replacements contact BD Customer Service Department at 1-800-675-0908 and all other inquiries contact BD Technical Services Department at 1-800-638-8663.
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.
Ortho clinical diagnostics issued a product correction notification for vitros immunodiagnostic products ca 125 ii reagent pack and calibrators due to a positive shift in patient results.
Acción
The firm, Ortho Clinical Diagnostics, sent a "IMPORTANT PRODUCT CORRECTION NOTIFICATION" letter dated October 9, 2013 to their clients/customers informing them of a shift in results that may be observed when performing patient sample correlation tests between VITROS CA 125 II Calibrators and Reagent Packs. The letter described the product, problem and actions to be taken. The customers were informed that it is acceptable to continue using any remaining inventory until its expiration date providing that quality control results are within acceptable limits (Note: Lots 1220 and 1230 are expired). The customers were also instructed to consider the need to review patient results using the affected lot(s). If you suspect that a previously reported result may have been affected, provide this information to your Laboratory Medical Director and the requesting physician or health care provider so that appropriate actions may be taken for the patients; Complete and return the attached Confirmation of Receipt form no later than October 18, 2013 via FAX TO: Ortho Clinical Diagnostics at 1-888-557-3759 or 1-585-453-4110, and Forward the information in this notification if you have distributed this product outside of your facility.
If you have any additional questions, please contact Customer Technical Services 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.
Nanosphere has received report of an increased rate of "no call - int ctl 2" results for the internal control 2 (int ctl 2) when negative samples are tested with certain lots of cdf amplification trays (20-011-022), which are contained in the cdf amplification reagent kit (20-012-022); specifically for lots 061913022d and 071813022e.
Acción
Nanosphere sent an Field Notification Letter dated October 16, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The letters included instructions for customers to: 1) discontinue use of the affected product, 2) discard any of the affected product, and 3) complete the attached form and return it to Nanosphere. Customers with questions can contact Nanosphere at 847-400-9000 or 888-837-4436 x 2.
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
in vitro diagnostic PSA - Product Code MTF
Causa
Product is not approved or authorized for distribution in the us.
Acción
A letter was issued on October 14, 2013 to consignees requesting the consignee to check their stock and destroy all kits of the VIDAS TPSA ref. 30428. The letter also requested that the consignee notify their accounts of the recall. An acknowledgment form was also included with the letter which is to be returned to BioMerieux.
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.
Nanosphere has received several reports relating to an increased rate of processing errors during procedures performed on the processor sp caused by tips in tip holder assemblies for the following products and lots of extraction trays.
Acción
Nanosphere sent a Field Notification Letter dated October 10, 2013, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Instructions were included in the letter for customers to determine whether or not the extraction tray lots should be returned. If the extraction tray lots are to be returned, customers were to complete and return the attached form and replacement tip holder assemblies will be supplied at no cost. Customers could then dispose of the recalled unused tip holder assemblies. Customers with questions were instructed to contact their Nanosphere technical support representative.
For questions regarding this recall call 1-888-837-4436, ext 3.