Food, drugs, devices › Tosoh Bioscience Inc
Device recall: Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the q
Tosoh Bioscience Inc (Grove City, OH) initiated this device recall on 5 Mar 2018; FDA lists 4 product records under event 79708, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 16 Jun 2020. Initiation: voluntary: firm initiated. Tosoh Bioscience Inc has 27 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Tosoh Bioscience Inc, Grove City, OH.
Reason for recall
"The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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. | 6049 | Class II | Terminated | 23 May 2018 |
| 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. | 1485 | Class II | Terminated | 23 May 2018 |
| 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. | 2864 | Class II | Terminated | 23 May 2018 |
| 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 | 2258 | Class II | Terminated | 23 May 2018 |
Context
Other enforcement events for Tosoh Bioscience Inc
All 27 events for Tosoh Bioscience Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Jun 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.