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Radiometer America Inc recalls HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose
Recalled December 31, 2014 · FDA recall Z-0873-2015 · Radiometer America
Hazard
Batches of HemoCue Glucose 201 Microcuvettes show discoloration and provide results outside the specification at the end of their shelf life, approx. after 6 months. The HemoCue Glucose 201 Analyzer with plasma conversion multiplies the measured whole blood glucose value by a factor of 1.11 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are for In Vitro Diag · FDA Class II
Units
3,712,900 microcuvettes
Sold at
Worldwide Distribution-US (nationwide) and the countries of Canada, Austria, AUSTRALIA, SWITZERLAND, COTE D'IVOIRE, CYPRUS, CZECH REPUBLIC, GERMANY, DENMARK, FINLAND, FRANCE, UNITED KINGDOM, GEORGIA, HONG KONG, CROATIA, HUNGARY, IRELAND, INDIA, ICELAND, JAPAN, KENYA, MACEDONIA, MALTA, NETHERLANDS, NORWAY, NEPAL, NEW ZEALAND, POLAND, ROMANIA, RUSSIA, SWEDEN, SLOVENIA, UNITED REPUBLIC OF TANZANIA, and SOUTH AFRICA.
Description
Batches of HemoCue Glucose 201 Microcuvettes show discoloration and provide results outside the specification at the end of their shelf life, approx. after 6 months. The HemoCue Glucose 201 Analyzer with plasma conversion multiplies the measured whole blood glucose value by a factor of 1.11 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are for In Vitro Diag
Product
HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. Affected lots identified initially were 110705, 110706, 110715, 110716, 110717, 110718, 110719, and 110720. Subsequent investigation also identified as affected lots 1310227, 1310252, and 1310257. HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials.
Manufacturer(s)
Radiometer America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →