Recall Z-2967-2020— Tosoh Bioscience Inc
Class II · Terminated
Class II FDA medical device recall by Tosoh Bioscience Inc, initiated 2020-08-07, terminated 2021-06-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay. Reason: Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%..
- Recalling firm
- Tosoh Bioscience Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-08-07
- Terminated
- 2021-06-21
- Firm location
- Grove City, OH, United States
Product description
Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
Reason for recall
Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%.
Data sourced from openFDA. This site is unofficial and independent of the FDA.