Recall Z-2091-2018— Tosoh Bioscience Inc
Class II · Terminated
Class II FDA medical device recall by Tosoh Bioscience Inc, initiated 2018-03-05, terminated 2020-08-31. FDA's recall record names no specific 510(k) clearance for this event. Product: ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone. Reason: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay..
- Recalling firm
- Tosoh Bioscience Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-05
- Terminated
- 2020-08-31
- Firm location
- Grove City, OH, United States
Product description
ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone
Reason for recall
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Data sourced from openFDA. This site is unofficial and independent of the FDA.