Use cautionMedical device recall · FDA · Published March 5, 2018
Tosoh HbA1c Control Recall: Erroneous Test Results Risk
Tosoh recalls HbA1c Control kits for inaccurate diabetes test results. Affected kits may give wrong blood sugar readings, causing health risks. Stop using immediately.
“Tosoh HbA1c Control Recall: Erroneous Test Results Risk.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/71778-tosoh-hba1c-control-recall-erroneous-test-results-risk. Based on FDA recall #Z-1811-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1811-2018%22&limit=1).
Tosoh Bioscience Inc recalled Tosoh ST AIA-PACK HbA1c Control (PN 025418) nationwide due to potentially erroneous HbA1c patient results, the FDA announced on March 5, 2018. The recall affects all lots of the product distributed across the United States.
How to tell if you have it
Brand: Tosoh
Product: Tosoh ST AIA-PACK HbA1c Control, HbA1c Control
Part Number: PN 025418
Lots: All lots
The hazard
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. The record does not report specific incidents or injuries.
Context
GovInfoNow's records show Tosoh Bioscience Inc has had 19 other recalls since June 11, 2017. Other recent recalls of similar products include the Tosoh ST AIA-Pack Testosterone Recall (June 12, 2026), the Tosoh AIA-Pack BHCG Calibrator Recall (Aug. 7, 2020), and the Tosoh AIA-900 Analyzer Recall (May 22, 2020). Other recent recalls of similar products include the Siemens Atellica CH A1c_E Test Recall (June 8, 2026), the FreeStyle Libre 14 Day Sensor Recall (Nov. 24, 2025), and the Siemens Atellica CH Urine Albumin Recall (July 6, 2026).
How to tell if you have this one
Check for the product name 'Tosoh ST AIA-PACK HbA1c Control' with part number PN 025418. All lots of this product are affected.
Brand
Tosoh
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
Recall number
Product, codes & lots
Quantity
Z-1809-2018
Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in the management and treatment of diabetes.; All lots.
6049
Z-1810-2018
Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay.; All lots.
1485
Z-1811-2018
Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the HbA1c Assay.; All lots.
2864
Z-1812-2018
Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay; All lots.
2258
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Look for the product name and part number PN 025418 on the kit packaging.
Stop Using Kit
If you have the affected kit, do not use it for diabetes testing until a replacement is obtained.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 36 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
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-1811-2018 (March 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1811-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 27, 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.