Home / Recalls / Tosoh Bioscience Inc / Z-0671-2019

Z-0671-2019 Class II Terminated

Recalled by Tosoh Bioscience Inc — Grove City, OH

Recall Details

Product Type
Devices
Report Date
January 2, 2019
Initiation Date
November 30, 2018
Termination Date
January 14, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
29645 units

Product Description

AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers.

Reason for Recall

Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays

Distribution Pattern

US Nationwide

Code Information

all lots

Other recalls by Tosoh Bioscience Inc

  • Z-2968-2020 Class II — Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagno (August 7, 2020)
  • 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-0675-2019 Class II — ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for (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-0674-2019 Class II — ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for (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-0676-2019 Class II — ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DI (November 30, 2018)
  • Z-0509-2019 Class II — AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product (October 5, 2018)