Recall Z-2092-2018— Tosoh Bioscience Inc
Class II · Terminated
Class II FDA medical device recall by Tosoh Bioscience Inc, initiated 2018-03-05, terminated 2020-08-31. It names one FDA 510(k) clearance: K143075. Product: ST-AIA PACK SHBG; Part Number: 025238 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
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ST-AIA PACK SHBG; Part Number: 025238 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.