FDA Device recall Z-2091-2018
ST-AIA PACK Prog II
- FDA Device
- Class II
- terminated
- Published 2018-06-13
On 2018-06-13 the FDA classified a Class II recall of ST-AIA PACK Prog II by Tosoh Bioscience, citing asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2091-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-05 |
| Published | 2018-06-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Tosoh Bioscience |
| Distribution | US |
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.
Identifiers
| code_info | All Lot Codes |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2091-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.