CLASS II Device recall · Reported 23 May 2018 · FDA Enforcement Report
Tosoh ST Aia-pack HbA1c, HbA1c Reagent, Pt recalled by Tosoh Bioscience
Tosoh Bioscience is recalling Tosoh ST Aia-pack HbA1c, HbA1c Reagent, Pt, distributed nationwide in the US. The recall was initiated on 5 Mar 2018 and the FDA has classified it as Class II.
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-1809-2018
- FDA event ID
- 79708
- Recalling firm
- Tosoh Bioscience, Grove City, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Mar 2018
- FDA classified
- 14 May 2018
- Reported
- 23 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 5 Mar 2018 | Recall initiated by company | |
| 14 May 2018 | Classified by FDA | +70 days |
| 23 May 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
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
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.
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIdahoIllinoisKansasKentuckyLouisianaMassachusettsMarylandMichiganMissouriNorth CarolinaNebraska
Questions about this recall
Is Tosoh ST Aia-pack HbA1c, HbA1c Reagent, Pt recalled?
Yes. Tosoh Bioscience recalled Tosoh ST Aia-pack HbA1c, HbA1c Reagent, Pt on 5 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-1809-2018.
Why was it recalled?
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
Which lots are affected?
All lots.
Where was it sold?
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.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 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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