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.
Reported: May 23, 2018 Initiated: March 5, 2018 #Z-1809-2018
Product Description
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.
Reason for Recall
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
Details
- Recalling Firm
- Tosoh Bioscience Inc
- Units Affected
- 6049
- 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.
- Location
- Grove City, OH
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Tosoh Bioscience Inc. Units affected: 6049.
Why was this product recalled? ▼
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 23, 2018. Severity: Moderate. Recall number: Z-1809-2018.
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