Class 2 Device Recall VITEK2 GPID

• Date Initiated by Firm: October 11, 2017
• Create Date: October 11, 2018
• Recall Status: Terminated on November 09, 2020
• Recall Number: Z-0074-2018
• Recall Event ID: 78288
• 510(K)Number: K952095
• Product Classification: Gram positive identification panel - Product Code LQL
• Product: VITEK2 GP-ID, REF 21342 IVD
• Code Information: UDI 03573026131920, Lot Number 2420348103
• FEI Number: 1950204
• Recalling Firm/ Manufacturer: Biomerieux Inc; 595 Anglum Rd; Hazelwood MO 63042-2320
• For Additional Information Contact: 314-731-8526
• Manufacturer 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.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = LQL