Home / Recalls / Tosoh Bioscience Inc / Z-2827-2018

Z-2827-2018 Class III Terminated

Recalled by Tosoh Bioscience Inc — Grove City, OH

Recall Details

Product Type
Devices
Report Date
August 22, 2018
Initiation Date
June 5, 2018
Termination Date
April 3, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9 CDS

Product Description

Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference section on assay controls in the analyte application manual.

Reason for Recall

Distribution of unapproved product labeling

Distribution Pattern

US Distribution to states of: FL, MA, MT, OK, OR and WI.

Code Information

rev: 6.0-040418

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-0671-2019 Class II — AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the (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-0674-2019 Class II — ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for (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)