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U.S. Department of Health and Human Services

Class 2 Device Recall VITEK2 GPID

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  Class 2 Device Recall VITEK2 GPID see related information
Date Initiated by Firm October 11, 2017
Create Date October 11, 2018
Recall Status1 Terminated 3 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
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, bioM¿rieux is also including in the scope of this notice all GP ID card lots manufactured with the same raw materials.
FDA Determined
Cause 2		 Under Investigation by firm
Action Consignees (Subsidiaries) of bioM¿rieux, 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 bioM¿rieux representative for credit or replacement. " Please store this letter with your bioM¿rieux system documentation. "Complete the attached Acknowledgement Form and return it to your local bioM¿rieux 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 and Original Applicant = BIOMERIEUX VITEK, INC.
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