Recalls / —
—#165596
Product
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 product code
- JST — Kit, Fastidious Organisms
- Device class
- Class 1
- Medical specialty
- Microbiology
- Affected lot / code info
- Batch/Lot: 245057043 Exp. Date 19JUN2019
Why it was recalled
Missing desiccant.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Biomerieux Inc
- Address
- 595 Anglum Rd, Hazelwood, Missouri 63042-2320
Distribution
- 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
Timeline
- Recall initiated
- 2018-01-23
- Terminated
- 2021-07-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #165596. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.