Diagnostica Stago, Inc. recalls Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model…

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.

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

On February 4, 2026 URGENT: MEDICAL DEVICE RECALL (REMOVAL) letters were sent to customers. Actions required: If you currently have one or more kits of STA LIATEST FREE PROTEIN S 6 : - For REF 00516: Lots 271971, 272859, and 273018 with a short expiration date we ask you to discontinue their use and dispose of them in accordance with your local regulations. Stago will provide a credit for any destroyed kits. - For REF 00516: lot 273426: o If the initial barcode sheet provided with the kit has already been loaded into the instrument: - Stop the use the initial barcode pre-calibration settings. - Replace the initial barcode settings with the new pre-calibration barcode settings attached, by following to the procedure described in Appendix 1 of this letter. o If the initial barcode sheet has not yet been loaded into the instrument: - Do not use it and proceed to load the lot using the new pre-calibration barcodes provided in the attachment.

• FDA enforcement recordOfficial FDA database entry for Z-1491-2026
• FDA 510(k) clearance · K010963The device's official FDA premarket clearance record
• FDA device classification · GGPOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.7290The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Diagnostica Stago, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.