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.
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 is FDA Class II, but involves a medical device where erroneous results pose a risk of harm. The rubric assigns a score of 3 for high-risk pathogens or risk-of-harm products where injury has not yet been reported.
Plain-English summary
Tosoh Bioscience Inc has initiated a recall of Tosoh ST AIA-PACK HbA1c Control, specifically PN 025418. The product is intended for in vitro diagnostic use only for performing quality control procedures with the HbA1c Assay.
The recall was issued because the assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. This issue affects all lots of the product, totaling 2864 units distributed nationwide in the USA, including Puerto Rico and specific states such as Alabama, Arkansas, Arizona, California, and others.
No further details regarding consumer actions or illness reports are provided in the source text.
The recalled product
- 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.
- Manufacturer
- Tosoh Bioscience Inc
- Hazard
- Affected units
- 2,864
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
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.
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