Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S ... recall (Diagnostica Stago, Inc.)
Medical deviceClass IIOngoing
Summary: Diagnostica Stago, Inc. is recalling 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 p. 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.
What is being recalled
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
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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; (states named: Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kentucky, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington)
How to tell if yours is affected
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
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1491-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 4, 2026 |
| Reported | March 11, 2026 |
| Company | Diagnostica Stago, Inc. |
| Company location | Parsippany, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 369 |
More recalls from Diagnostica Stago, Inc. · all medical device recalls · recalls from February 2026