The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1810-2018·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 that may generate erroneous diagnostic results, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Tosoh Bioscience Inc is recalling the Tosoh ST AIA-PACK HbA1c Calibrator (PN 025318). The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay.

The recall was initiated because the assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. The source text does not specify reported illnesses, injuries, or fatalities associated with this recall.

The recall covers 1,485 units distributed nationwide in the USA, including Puerto Rico and specific states. All lots are affected. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled product.

The recalled product

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.
Manufacturer
Tosoh Bioscience Inc
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
1,485

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 →

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