FDA Medical Device Recalls (openFDA)
Biomerieux Inc: 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.
- Recall number
- Z-2874-2018
- Recalling firm
- Biomerieux Inc
- 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.
- Status
- Terminated
- Initiated
- 2018-01-23
- Posted
- not on file
- Terminated
- 2021-07-13
- Reason
- Missing desiccant.
- Root cause
- Nonconforming Material/Component
- 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.
- Quantity
- 57 cartons
- Distribution
- 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
- Lot, serial or model codes
- Batch/Lot: 245057043 Exp. Date 19JUN2019
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JST
- Firm FEI
- 1950204
- Firm city
- Hazelwood
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28