bioMrieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.
FDA Recall Z-2874-2018 · Posted None
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Recalling FirmBiomerieux Inc
Recall StatusTerminated
Product CodeJST
Date Initiated2018-01-23
Date Terminated2021-07-13
Product Quantity57 cartons
Reason for Recall
Missing desiccant.
Firm Action
bioMrieux sent to customers letter requesting the following actions;
- Please confirm this letter has been distributed and reviewed by all appropriate personnel within your organization.
- Please dispose of any VITEK 2 NH ID test kits, Lot 2450570403, in your stock that were received prior to 25-JAN-2018 and do not have a blue sticker on the carton. Please contact your local bioMrieux representative for replacement of destroyed test kits.
- Please store this letter with your bioMrieux VITEK 2 System documentation.
- Complete the attached Acknowledgement Form and return it to your local bioMrieux representative.
bioMrieux, Inc. is committed to providing our customers with the highest quality products, and we apologize for any inconvenience this has caused your business. If you have any questions or concerns, please contact your local bioMrieux representative.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT. VA. VT. WA. WI, and WV
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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