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.
Reported: May 23, 2018 Initiated: March 5, 2018 #Z-1811-2018
Product Description
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.
Reason for Recall
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
Details
- Recalling Firm
- Tosoh Bioscience Inc
- Units Affected
- 2864
- 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 Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the HbA1c Assay.. Recalled by Tosoh Bioscience Inc. Units affected: 2864.
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-1811-2018.
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