Tosoh recalls Hemoglobin A1c Control (Lot 7055) due to potential degradation affecting lab test accuracy. This may cause delays in patient results. No serious injuries reported.
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.
Tosoh recalls a specific lot of Hemoglobin A1c Control materials for lab use because they might degrade, leading to inaccurate test results and delays in patient testing. This affects laboratories that use these controls for quality checks.
The control materials may degrade before their 60-day stability period, causing test results to drift outside acceptable ranges. This could lead to delays in reporting patient test results if the lab relies on these controls for quality assurance.
Laboratories using the recalled Hemoglobin A1c Control lot #7055 for routine quality checks are affected. Those handling lab testing procedures are most at risk of delayed patient results.
Check for the product name 'Hemoglobin A1c Control' with part number 220232 and lot number 7055. This specific lot was recalled by Tosoh Bioscience.
Look for the lot number 7055 on the product label to confirm if it is affected.
No serious injuries have been reported with this recall, but there may be delays in patient test results.
Check for the product name 'Hemoglobin A1c Control' with part number 220232 and lot number 7055.
The recall does not specify a remedy, so contact Tosoh Bioscience for further instructions.
We’ve drafted a message you can send Tosoh Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-0601-2019 — Tosoh Bioscience Tosoh Bioscience Hello, I own a Tosoh Bioscience that is covered by recall Z-0601-2019 from Tosoh Bioscience. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
