Device product
Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
Z-2968-2020
Product summary
- Event
- Event 86218
- Status
- Terminated
- Classification
- Class II
- Quantity
- 39 boxes
- Official record key
device-enforcement:Z-2968-2020
Official wording
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%.
Code information: Lot Numbers: J803507, JX03508, JZ03509, A203510, A403511
Distribution pattern: Worldwide Distribution: US (Nationwide) and countries of: Bogota, Cayman Islands, Mexico, Peru, and San Salvador.
Derived failure modes
-
Unknown
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%.