Z-1491-2026Class II

Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF)...

Name: Z-1491-2026 Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF)...
Creator: Diagnostica Stago, Inc.
Published: 2026-02-04
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2026-02-04 / Open, Classified

FDA source

Diagnostica Stago, Inc. began a recall of 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... on 2026-02-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1491-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-04
Posted: 2026-03-03
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
Product code: GGP Test, Qualitative And Quantitative Factor Deficiency
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.
FDA 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. - 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.
Quantity in commerce: 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, 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 codes and lots: Model/Catalog Number (REF): 00516; UDI: (1) (01)03607450005165(11)241001(17)260131(10)271971(241)00516, (2) (01)03607450005165(11)250221(17)260531(10)272859(241)00516, (3) (01)03607450005165(11)250306(17)260630(10)273018(241)00516, (4) (01)03607450005165(11)250430(17)260831(10)273426(241)00516; Lot numbers: (1) 271 971, (2) 272 859, (3) 273 018, (4) 273 426; Lot Code: 271 971 (01)03607450005165(11)241001(17)260131(10)271971(241)00516

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1491-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1491-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-11	2026-03-03

Product code GGP

K010963Class IISta-Liatest Free Protein S Test KitDiagnostica Stago, Inc. / cleared 2001-06-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)