The Recall Desk
HighFDA (Devices)·Z-1809-2018·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk-of-harm where inaccurate test results could affect patient care, but no illnesses or injuries have been reported in the source text. This aligns with the High severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Tosoh Bioscience Inc has initiated a recall of the Tosoh ST AIA-PACK HbA1c Reagent, Part Number 025218. This in vitro diagnostic device is used for the quantitative measurement of Hemoglobin A1c (HbA1c) percent concentration in EDTA whole blood on the Tosoh AIA System Analyzer. The results from this test are utilized in the management and treatment of diabetes.

The recall was prompted by the potential for the assay to generate erroneously elevated or erroneously decreased HbA1c patient results. Such inaccurate readings could impact clinical decisions regarding diabetes care.

The affected product includes all lots of the reagent, with a total quantity of 6,049 units distributed nationwide across the United States, including Puerto Rico and numerous specific states such as California, Florida, New York, and Texas.

Healthcare providers and consumers should check their inventory against the recalled lot numbers and discontinue use of the affected reagents. Proper disposal or return procedures should be followed according to manufacturer guidelines.

The recalled product

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 th
Manufacturer
Tosoh Bioscience Inc
Category
Medical Device — In Vitro Diagnostic Reagent
Hazard
Affected units
6,049

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots.

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Tosoh Bioscience Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Tosoh Bioscience Inc

See all →

Same hazard · mis diagnosis risk

See all →