—#158270

Product

VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria

FDA product code: LQL — Gram Positive Identification Panel
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K952095
Affected lot / code info: Lot Number 2420240403, Exp. 24-JUL-18, 2420303403, Exp 24-SEP-2018

Why it was recalled

Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC(R) 700327(TM) in association with VITEK(R) 2 GP ID Lot 2420240403 and 2420303403, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card. The expected O129R reaction for ATCC 700327(TM) strain is positive.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

bioMerieux sent an Urgent Product Removval Notice to all affected consignees (Subsidiaries) of bioMrieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on August 25, 2017. . 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 and 2420303403) 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." Consignees with questions were instructed to contact their local representative.

Recalling firm

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

Distribution

Distribution pattern: US and Angola, Argentina, Austria, Belarus, Belgium, Burkina Faso, Cameroon, Canada, China, Congo, Croatia, Egypt, France, Germany, Greece, Guam, Hungary, Israel, Italy, Latvia, Luxembourg, Macedonia, Mali, Mexico, Morocco, Netherlands, Nicaragua, Oman, Panama, Poland, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Swaziland, Switzerland, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom

Timeline

Recall initiated: 2017-08-25
Terminated: 2020-11-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #158270. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.