Home / Recalls / Tosoh Bioscience Inc / Z-2968-2020

Z-2968-2020 Class II Terminated

Recalled by Tosoh Bioscience Inc — Grove City, OH

Recall Details

Product Type
Devices
Report Date
September 23, 2020
Initiation Date
August 7, 2020
Termination Date
June 21, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
39 boxes

Product Description

Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay

Reason for Recall

Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%.

Distribution Pattern

Worldwide Distribution: US (Nationwide) and countries of: Bogota, Cayman Islands, Mexico, Peru, and San Salvador.

Code Information

Lot Numbers: J803507, JX03508, JZ03509, A203510, A403511

Other recalls by Tosoh Bioscience Inc

  • Z-2967-2020 Class II — Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part (August 7, 2020)
  • Z-2423-2020 Class II — AIA-900 Analyzer, Part no. 022930, UDI 04560189283992 (May 22, 2020)
  • Z-1420-2020 Class II — AIA-360 Automated Immunoassay Analyzer, Product Code 019945 (January 10, 2020)
  • Z-0676-2019 Class II — ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DI (November 30, 2018)
  • Z-0672-2019 Class II — AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quant (November 30, 2018)
  • Z-0675-2019 Class II — ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for (November 30, 2018)
  • Z-0671-2019 Class II — AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the (November 30, 2018)
  • Z-0673-2019 Class II — ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC (November 30, 2018)
  • Z-0674-2019 Class II — ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for (November 30, 2018)
  • Z-0601-2019 Class III — Hemoglobin A1c Control, Part no. 220232 for use as quality control material to m (October 5, 2018)