Device 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
Z-2967-2020
Product summary
- Event
- Event 86218
- Status
- Terminated
- Classification
- Class II
- Quantity
- 289 boxes
- Official record key
device-enforcement:Z-2967-2020
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: J833531, JX33532, JZ33533, A233534, A433535
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%.