Device product
AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid
Z-2077-2018
Product summary
- Event
- Event 79813
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5293
- Official record key
device-enforcement:Z-2077-2018
Official wording
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 information: All Lot Codes
Distribution pattern: Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.
Derived failure modes
-
Unknown
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.