Diagnostica Stago, Inc.: Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: Th

Company / brand

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

Reason / hazard

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.

Classification

Class II

Status

Ongoing

Distribution / sold at

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;

Recall initiated

2026-02-04

Code info

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

Product quantity

369

Voluntary mandated

Voluntary: Firm initiated

City

Parsippany

State

NJ

Country

United States

Event id

98394

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