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Z-3134-2017 Class II Terminated

Recalled by Biomerieux Inc — Hazelwood, MO

FDA device recall Z-3134-2017 was initiated by Biomerieux Inc on August 25, 2017 and is designated Class II. Reason for recall: 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, … The recall status is terminated (terminated November 9, 2020). Affected quantity: 11,703 cartons.

Recall Details

Product Type
Devices
Report Date
September 27, 2017
Initiation Date
August 25, 2017
Termination Date
November 9, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,703 cartons

Product Description

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

Reason for Recall

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.

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

Code Information

Lot Number 2420240403, Exp. 24-JUL-18, 2420303403, Exp 24-SEP-2018

Other recalls by Biomerieux Inc

  • Z-2715-2026 Class II — VITEK 2 AST-N447 TEST KIT Product reference 424620 (June 4, 2026)
  • Z-1236-2026 Class II — VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ce (January 5, 2026)
  • Z-2671-2025 Class II — VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs0 (June 26, 2025)
  • Z-1464-2024 Class I — VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial suscep (March 14, 2024)
  • Z-1201-2023 Class II — MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connec (February 6, 2023)
  • Z-0848-2023 Class II — VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915 (November 9, 2022)
  • Z-0790-2023 Class II — VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345 (November 9, 2022)
  • Z-0810-2023 Class II — API JAMES 2AMP, CATALOG 70542 (November 9, 2022)
  • Z-0794-2023 Class II — PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588 (November 9, 2022)
  • Z-0802-2023 Class II — PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841 (November 9, 2022)

FDA data resources