Vitek2 Gp-Id, Ref 21342 Ivd recallZ-0074-2018 · Biomerieux Inc · initiated Oct 11, 2017

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Biomerieux Inc or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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."

Recall details

Recall number: Z-0074-2018
Status: Terminated
Initiated by the company: Oct 11, 2017
Recalling firm: Biomerieux Inc
Quantity: 5672 cartons
Product code: LQL
FDA submissions: K952095
Distribution: worldwide

Product description

VITEK2 GP-ID, REF 21342 IVD

Code information (models, lots, serial numbers)

UDI 03573026131920, Lot Number 2420348103

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

VITEK® 2 GP
Biomerieux , Inc. · Gram positive identification panel
2 recalls103 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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