FDA Enforcement
Class II
Terminated
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
Recall: Z-2967-2020
·
Reported September 23, 2020
Enforcement
- Recall Number
- Z-2967-2020
- Event ID
- 86218
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Tosoh Bioscience Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 23, 2020
- Initiation Date
- August 7, 2020
- Classification Date
- September 14, 2020
- Termination Date
- June 21, 2021
- Address
- 3600 Gantz Rd, N/A, Grove City, OH, 43123-1895, United States
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
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 Info
Lot Numbers: J833531, JX33532, JZ33533, A233534, A433535
Distribution
Worldwide Distribution: US (Nationwide) and countries of: Bogota, Cayman Islands, Mexico, Peru, and San Salvador.
Quantity
289 boxes