—#159072

Product

VITEK2 GP-ID, REF 21342 IVD

FDA product code: LQL — Gram Positive Identification Panel
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K952095
Affected lot / code info: UDI 03573026131920, Lot Number 2420348103

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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."

Recalling firm

Firm: Biomerieux Inc
Address: 595 Anglum Rd, Hazelwood, Missouri 63042-2320

Distribution

Distribution pattern: worldwide

Timeline

Recall initiated: 2017-10-11
Terminated: 2020-11-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #159072. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.