Reported Dec 19, 2018 · Terminated
Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory…
Tosoh Bioscience Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tosoh Bioscience Inc · 3600 Gantz Rd · Grove City, OH · 43123-1895
Is this the product you have?
- Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
- Lot codes and dates
- Lot 7055
- Amount recalled
- 1000
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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