STA Liatest Free Protein recalled by Diagnostica Stago

Timeline

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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;

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