Recall Z-1491-2026— Diagnostica Stago, Inc.

Name: FDA recall Z-1491-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-04

Class II · Ongoing

Class II FDA medical device recall by Diagnostica Stago, Inc., initiated 2026-02-04. It names one FDA 510(k) clearance: K010963. 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..

Recalling firm: Diagnostica Stago, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-02-04
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K010963 — STA-LIATEST FREE PROTEIN S TEST KITDiagnostica Stago, Inc.·cleared 2001-06-06

K-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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.