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.
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 is classified as FDA Class II, and the hazard involves potential diagnostic errors (erroneous results) which constitute a risk of harm 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 Pretreatment Solution, Product Number 025718. The recall covers 2,258 units distributed nationwide in the United States, including Puerto Rico and 38 specific states. The device is intended for in vitro diagnostic use only for the pretreatment of patient samples or control sets for the HbA1c assay.
The recall was initiated because the assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. This defect may lead to inaccurate diagnostic information for patients undergoing HbA1c testing.
Healthcare facilities and laboratories that have received this product should stop using it and contact Tosoh Bioscience Inc for further instructions. Consumers should consult their healthcare providers regarding any HbA1c tests performed using this specific solution.
The recalled product
- 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
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 2,258
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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