Home / Recalls / Biomerieux Inc / Z-1596-2016

Z-1596-2016 Class II Terminated

Recalled by Biomerieux Inc — Hazelwood, MO

FDA device recall Z-1596-2016 was initiated by Biomerieux Inc on Feb 24, 2016 and is designated Class II. Reason for recall: Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline. The recall status is terminated (terminated May 26, 2017). Affected quantity: 337 Kits of 20 Cards/Kit.

Recall Details

Product Type
Devices
Report Date
May 11, 2016
Initiation Date
Feb 24, 2016
Termination Date
May 26, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
337 Kits of 20 Cards/Kit

Product Description

VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 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. The VITEK 2 System is not considered a life supporting/sustaining device and does not deliver any type of energy or substance to the patient. The VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.

Reason for Recall

Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline.

Distribution Pattern

Worldwide Distribution to China  Taiwan region; No US/military/government distribution.

Code Information

Lot/Serial: 485368220 Expiry: 12-JAN-17

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1596-2016
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Biomerieux Inc

  • Z-3231-2026 Class II — VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED… (Jul 24, 2026)
  • Z-2715-2026 Class II — VITEK 2 AST-N447 TEST KIT Product reference 424620 (Jun 4, 2026)
  • Z-1236-2026 Class II — VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n)… (Jan 5, 2026)
  • Z-2671-2025 Class II — VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation… (Jun 26, 2025)
  • Z-1464-2024 Class I — VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial… (Mar 14, 2024)
  • Z-1201-2023 Class II — MYLA comprises AST Filters in conjunction with VITEK MS; middleware which… (Feb 6, 2023)
  • Z-0848-2023 Class II — VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915 (Nov 9, 2022)
  • Z-0794-2023 Class II — PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588 (Nov 9, 2022)
  • Z-0827-2023 Class II — ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401 (Nov 9, 2022)
  • Z-0840-2023 Class II — GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057 (Nov 9, 2022)

FDA data resources