Device product

ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes

Z-2076-2018

March 05, 2018

Class II

Product summary

Firm: Tosoh Bioscience Inc
Event: Event 79813
Status: Terminated
Classification: Class II
Quantity: 9625
Official record key: device-enforcement:Z-2076-2018

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
reason.no_named_rule · v1.0.0

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.