FDA Enforcement
Class II
Terminated
AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid
Recall: Z-2077-2018
·
Reported June 13, 2018
Enforcement
- Recall Number
- Z-2077-2018
- Event ID
- 79813
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Tosoh Bioscience Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 13, 2018
- Initiation Date
- March 5, 2018
- Classification Date
- June 5, 2018
- Termination Date
- August 31, 2020
- Address
- 3600 Gantz Rd, N/A, Grove City, OH, 43123-1895, United States
Description
AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid
Reason
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Code Info
All Lot Codes
Distribution
Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.
Quantity
5293