Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Hemoglobin A1c Control Recalled by Tosoh Bioscience Inc Due to Tosoh Bioscience has become aware of potential degradation...
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
Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
Quantity: 1000
Why Was This Recalled?
Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days product stability claim. If degradation of these controls occurs, P00 peaks may be seen and the % HbA1c control values may drift higher than the assigned range. This may result in delays when performing routine instrument quality control. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received two (2) complaints related to this issue with no serious injuries reported.
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