Home / Recalls / bioMerieux, Inc. / Z-2339-2017

Z-2339-2017 Class II Terminated

Recalled by bioMerieux, Inc. — Durham, NC

Recall Details

Product Type
Devices
Report Date
July 19, 2017
Initiation Date
May 15, 2017
Termination Date
June 11, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
742

Product Description

VIDAS Testosterone, Ref 30418

Reason for Recall

Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone.

Distribution Pattern

AR, CA, CO, GA, IL, IA, MI, MN, MT, NY, OK, TN, TX, WY, Columbia, Costa Rica, El Salvador, France, Hong Kong, Jordan, Nicaragua, Russian Fed., Sri Lanka, Sweden, Ukraine

Code Information

Lots 1004878310 & 1005001080

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  • 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-0795-2023 Class II — VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217 (November 9, 2022)
  • Z-0856-2023 Class II — VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416 (November 9, 2022)
  • Z-0791-2023 Class II — VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346 (November 9, 2022)
  • Z-0871-2023 Class II — PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR (November 9, 2022)
  • Z-0824-2023 Class II — ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333 (November 9, 2022)
  • Z-0852-2023 Class II — ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560 (November 9, 2022)