Home / Recalls / Tosoh Bioscience Inc / Z-2069-2018

Z-2069-2018 Class II Terminated

Recalled by Tosoh Bioscience Inc — Grove City, OH

Recall Details

Product Type
Devices
Report Date
June 13, 2018
Initiation Date
March 5, 2018
Termination Date
August 31, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4824

Product Description

ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker

Reason for Recall

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

Distribution Pattern

Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.

Code Information

All Lot Codes

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-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-0676-2019 Class II — ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DI (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-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)