Z-2967-2020 Class II Terminated
FDA device recall Z-2967-2020 was initiated by Tosoh Bioscience Inc on August 7, 2020 and is designated Class II. 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%. The recall status is terminated (terminated June 21, 2021). Affected quantity: 289 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2020
- Initiation Date
- August 7, 2020
- Termination Date
- June 21, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 289 boxes
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%.
Distribution Pattern
Worldwide Distribution: US (Nationwide) and countries of: Bogota, Cayman Islands, Mexico, Peru, and San Salvador.
Code Information
Lot Numbers: J833531, JX33532, JZ33533, A233534, A433535