Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free… — Class II medical device recall Z-1491-2026
Ongoing recall by Diagnostica Stago, Inc., reported 2026-03-11, distributed nationwide. The potential of out-of-range results and an underestimation of the free protein S level in normal patient pla
| Recall number | Z-1491-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diagnostica Stago, Inc., Parsippany, NJ, United States |
| Recall initiated | 2026-02-04 |
| Classified | 2026-03-03 |
| Reported by FDA | 2026-03-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CR, DE, DK, DZ, ES, FI, FR, GB, GR, GT, IE, IN, IQ, IT, JO, KE, KR, LU, MA, MX, MY, NL, NZ, PK, PT, PY, RO, RS, SA, SE, TH, TR, TW, UY, ZA |
| Quantity | 369 |
| UPC / GTIN / UDI-DI | 03607450005165 |
| Lot numbers | 018, 271, 272, 273, 426, 859, 971 |
| Model numbers | 00516, 018, 271, 272, 273, 426, 859, 971 |
Product
Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - Liatest¿ Free Protein S kits are intended for use on STA-R¿ and STA Compact¿ for the quantitative antigenic assay of free protein S in human citrated plasma by the immuno-turbidimetric method. Component: Not Applicable
Reason for recall
The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1491-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.