FDA Medical Device Recalls (openFDA)
Biomerieux Inc: VITEK2 GP-ID, REF 21342 IVD
- Recall number
- Z-0074-2018
- Recalling firm
- Biomerieux Inc
- Product
- VITEK2 GP-ID, REF 21342 IVD
- Status
- Terminated
- Initiated
- 2017-10-11
- Posted
- not on file
- Terminated
- 2020-11-09
- Reason
- Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R) 700327(TM) in association with three (3) VITEK(R) 2 GP ID Lots, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card. In accordance with the VITEK(R) 2 GP ID Instructions For Use, the expected O129R reaction for ATCC(R) 700327(TM) strain is positive. As a precaution, bioMrieux is also including in the scope of this notice all GP ID card lots manufactured with the same raw materials.
- Root cause
- Under Investigation by firm
- Action
- Consignees (Subsidiaries) of bioMrieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on 10/11/2017. The direct consignees (subsidiaries and distributors) have until 11/11/2017 to notify their respective impacted users. The directions to the user are as follows: "Please implement the following actions at this time: We request you take the following action at this time: " Please confirm this letter has been distributed and reviewed by all appropriate personnel within your organization. " Please refrain from using the referenced test kits (VITEK 2 GP ID, Lots 2420240403, 2420303403, and 2420348103) in your laboratory. Destroy any of this product in your inventory, and contact your local bioMrieux representative for credit or replacement. " Please store this letter with your bioMrieux system documentation. "Complete the attached Acknowledgement Form and return it to your local bioMrieux representative."
- Quantity
- 5672 cartons
- Distribution
- worldwide
- Lot, serial or model codes
- UDI 03573026131920, Lot Number 2420348103
- 510(k) numbers
- ["K952095"]
- PMA numbers
- not on file
- Product code
- LQL
- 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