The Recall Desk

FDA (Devices) recall action 79708

Tosoh Bioscience Inc recalled 4 products on 2018-05-23

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2018-05-23
Critical
0
Units
12,656

Why these products were recalled

The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··2018-05-23

    Tosoh HbA1c Pretreatment Solution Recalled for Potential Inaccurate Test Results

    Tosoh Bioscience Inc is recalling HbA1c Pretreatment Solution because it may cause erroneously elevated or decreased patient test results.

    Product
    Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2018-05-23

    Tosoh Bioscience Recalls HbA1c Reagent Due to Potential Test Errors

    Tosoh Bioscience Inc is recalling Tosoh ST AIA-PACK HbA1c reagents because the assay may produce erroneously high or low Hemoglobin A1c results.

    Product
    Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2018-05-23

    Tosoh Bioscience Recalls HbA1c Control Due to Erroneous Results

    Tosoh Bioscience Inc is recalling Tosoh ST AIA-PACK HbA1c Control because the product may generate erroneously elevated or decreased HbA1c patient results.

    Product
    Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the HbA1c Assay.
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2018-05-23

    Tosoh HbA1c Calibrator Recalled for Potential Inaccurate Patient Results

    Tosoh Bioscience Inc is recalling HbA1c Calibrators because they may cause erroneous patient test results.

    Product
    Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay.
    Category
    Distribution
    37 states