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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79708

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 05, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Tosoh Bioscience Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

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.

Z-1809-2018
Recall number
Z-1809-2018
Initiated
March 05, 2018
Classification
Class II
Status
Terminated
Recalling firm
Tosoh Bioscience Inc
Quantity
6049

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.

Code information

All lots.

Distribution pattern

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.

device · product 2 of 4

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.

Z-1810-2018
Recall number
Z-1810-2018
Initiated
March 05, 2018
Classification
Class II
Status
Terminated
Recalling firm
Tosoh Bioscience Inc
Quantity
1485

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.

Code information

All lots.

Distribution pattern

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.

device · product 3 of 4

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.

Z-1811-2018
Recall number
Z-1811-2018
Initiated
March 05, 2018
Classification
Class II
Status
Terminated
Recalling firm
Tosoh Bioscience Inc
Quantity
2864

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.

Code information

All lots.

Distribution pattern

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.

device · product 4 of 4

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

Z-1812-2018
Recall number
Z-1812-2018
Initiated
March 05, 2018
Classification
Class II
Status
Terminated
Recalling firm
Tosoh Bioscience Inc
Quantity
2258

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.

Code information

All lots.

Distribution pattern

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.