[Recalled] ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker — Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially… | FDA 2018-03-05
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker |
|---|---|
| Brand / manufacturer | Tosoh Bioscience Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2066-2018 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 05 March 2018 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Tosoh Bioscience Inc
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.