Recall Z-1811-2018— Tosoh Bioscience Inc
Class II · Terminated
Class II FDA medical device recall by Tosoh Bioscience Inc, initiated 2018-03-05, terminated 2020-06-16. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results..
- Recalling firm
- Tosoh Bioscience Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-05
- Terminated
- 2020-06-16
- Firm location
- Grove City, OH, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.