Z-0074-2018Class II

Vitek2 Gp-Id, Ref 21342 IVD

Name: Z-0074-2018 Vitek2 Gp-Id, Ref 21342 IVD
Creator: Biomerieux Inc
Published: 2017-10-11
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2017-10-11 / Terminated / root cause: labeling and UDI

FDA source

Biomerieux Inc began a recall of VITEK2 GP-ID, REF 21342 IVD on 2017-10-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0074-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-11
Posted: 2018-10-11
Terminated: 2020-11-09
Recalling firm: bioMerieux, Inc.
Product: Vitek2 Gp-Id, Ref 21342 IVD
Product code: LQL Gram Positive Identification Panel
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 5672 cartons
Distribution: worldwide
Product codes and lots: UDI 03573026131920, Lot Number 2420348103

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0074-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0074-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-15	2017-11-08

Product code LQL

K952095Class IVitek Gram Positive Identification Card (Gpi)Biomerieux Vitek, Inc. / cleared 1996-03-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)