Lower riskMedical device recall · FDA · Published October 5, 2018
Tosoh Hemoglobin A1c Control Recall: Degradation Risk in Lab Testing
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.
Take action
Contact the company
📍Recalling firmTosoh Bioscience Inc3600 Gantz Rd · Grove City, OH 43123-1895
“Tosoh Hemoglobin A1c Control Recall: Degradation Risk in Lab Testing.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69662-tosoh-hemoglobin-a1c-control-recall-degradation-risk-in-lab-testing. Based on FDA recall #Z-0601-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0601-2019%22&limit=1).
The FDA announced on Oct. 5, 2018, that Tosoh Bioscience Inc recalled Hemoglobin A1c Control, Part no. 220232, due to potential degradation before the stability claim. The agency said the recall is voluntary and concerns lot #7055 distributed nationwide and to Canada.
How to tell if you have it
Brand: Tosoh Bioscience
Product: Hemoglobin A1c Control, Part no. 220232
Lot code: 7055
The hazard
The FDA said the control may degrade before the 60-day stability claim, causing P00 peaks and higher % HbA1c values. This may delay routine instrument quality control and patient test reporting. The company received two complaints with no serious injuries reported.
Context
GovInfoNow's records show Tosoh Bioscience Inc has had 19 other recalls since June 11, 2017. Other recent recalls of similar products include Tosoh ST AIA-Pack Testosterone Recall (June 12, 2026), Tosoh Bioscience AIA-PACK BHCG Test Set Recall (Aug. 7, 2020), and Tosoh AIA-900 Analyzer Recall (May 22, 2020). Other recent recalls of similar products include Siemens Atellica CH A1c_E Test Recall (June 8, 2026), HemosIL SynthAFax Partial Thromboplastin Time Tests Recall (Nov. 18, 2025), and Siemens Atellica CH Urine Albumin Recall (July 6, 2026).
How to tell if you have this one
Check for the product name 'Hemoglobin A1c Control' with part number 220232 and lot number 7055. This specific lot was recalled by Tosoh Bioscience.
Brand
Tosoh Bioscience
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for the lot number 7055 on the product label to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Distributed nationwide. Foreign distribution to Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0601-2019 (October 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0601-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.