Brand Name: STA Liatest Free Protein S recallZ-1491-2026 · Diagnostica Stago, Inc. · initiated Feb 4, 2026

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number

Z-1491-2026

Status

Open, Classified

Initiated by the company

Feb 4, 2026

Posted by the FDA

Mar 3, 2026

Recalling firm

Diagnostica Stago, Inc.

Quantity

369

Product code

GGP

FDA submissions

K010963

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, COSTA RICA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, GUATEMALA, INDIA, IRAQ, IRELAND, ITALY, JORDAN, KENYA, KOREA REPUBLIC OF, LITUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, PAKISTAN, PALESTINIAN TERRITORY, PARAGUAY, PORTUGAL, ROMANIA, RUSSIE, SAUDI ARABIA, SERBIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIE, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY;

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• STA® - Liatest® Free Protein S 6 00516

  Diagnostica Stago · TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY
  1 recall0 reports