CLASS III Device recall · Reported 19 Dec 2018 · FDA Enforcement Report
Hemoglobin A1c Control recalled by Tosoh Bioscience
Tosoh Bioscience is recalling Hemoglobin A1c Control, distributed nationwide in the US. The recall was initiated on 5 Oct 2018 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0601-2019
- FDA event ID
- 81188
- Recalling firm
- Tosoh Bioscience, Grove City, OH
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Oct 2018
- FDA classified
- 13 Dec 2018
- Reported
- 19 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Patient Monitors
Timeline
| 5 Oct 2018 | Recall initiated by company | |
| 13 Dec 2018 | Classified by FDA | +69 days |
| 19 Dec 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
Where it was distributed
Distributed nationwide. Foreign distribution to Canada.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot 7055
Where was it sold?
Distributed nationwide. Foreign distribution to Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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