Recall Z-1491-2026 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
Diagnostica Stago, Inc.
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
| Date | Mar 3, 2026 (initiated Feb 4, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 369 |
| Distribution | Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IL, KY, MI, MN, MO, MT, NC, ND, NJ, NY, OH, PA, TN, TX, UT, VA, WA and the countries of ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BIELORUSSIE, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010963 | STA-LIATEST FREE PROTEIN S TEST KIT Diagnostica Stago, Inc., Jun 6, 2001 |