FDA-Device2026-03-11Class IIPROCESSING DEFECT
Diagnostica Stago STA Liatest Free Protein S kits recalled for inaccurate test results
What this means
Diagnostica Stago's STA Liatest Free Protein S testing kits (model REF 00516) may produce inaccurate results, potentially underestimating free protein S levels in normal patient samples. This affects specific lot numbers distributed nationwide and internationally. No injuries have been reported.
- If you use this kit, check if your lot number matches the recalled batches (271 971, 272 859, 273 018, or 273 426)
- Contact Diagnostica Stago for guidance on affected test results and next steps
- Review any patient test results from affected lot numbers for potential retesting
The agency's original wording
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.
Intended for
All ages
Illnesses reported
None reported
Sold states
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;
Affected count
369
Manufactured in
5 Century Dr, N/A, Parsippany, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1491-2026More Diagnostica Stago recalls
- FDA-Device2026-09-09Diagnostica Stago STA Staclot Protein S reagent recalled for QC drift
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