Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Tosoh ST AIA-PACK HbA1c Calibrator Recalled by Tosoh Bioscience Inc Due to The assay can potentially generate erroneously elevated or...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Tosoh Bioscience Inc directly.
Affected Products
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.
Quantity: 1485
Why Was This Recalled?
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Tosoh Bioscience Inc
Tosoh Bioscience Inc has 68 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report