Tosoh Recalls Hemoglobin A1c Control Material Due to Potential Degradation
Tosoh Bioscience is recalling Hemoglobin A1c Control material due to potential degradation that may cause testing delays.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classification is Class III, which is defined as unlikely to cause adverse health consequences. The source text explicitly states that no serious injuries have been reported, and the primary impact is a delay in testing rather than direct physical harm.
Plain-English summary
Tosoh Bioscience Inc is recalling 1,000 units of Hemoglobin A1c Control, Part no. 220232, Lot 7055. This product is used as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
The recall was initiated because the company became aware of potential degradation of the control material before the 60-day product stability claim. If degradation occurs, P00 peaks may appear, and the % HbA1c control values may drift higher than the assigned range. This issue may result in delays when performing routine instrument quality control, potentially leading to delays in testing and reporting patient test results.
The product was distributed nationwide and to Canada. Tosoh has received two complaints related to this issue, with no serious injuries reported.
The recalled product
- Product
- Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 1,000
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)
- Lot 7055
Distribution
Distributed nationwide across the United States.
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