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

Recalling firm
Diagnostica Stago, Inc.
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
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.
Classification
Class II
Category
consumer product recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-02-04
Status
Open, Classified

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/1ceb805d-2d3b-4871-abcd-3fb4b50a3096