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HemoCue AB recalls HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes a
Recalled September 18, 2013 · FDA recall Z-2190-2013 · HemoCue AB
Hazard
During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches. · FDA Class II
Units
22,215 boxes of 100 cuvettes distributed in US, 34, 841 distributed outside the US
Sold at
Worldwide Distribution - USA (nationwide) and internationally to AUSTRALIA, BELGIUM, CANADA, COTE D'IVOIRE, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, IRELAND, ITALY, KENYA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, QATAR, RUSSIAN FEDERATION, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM, VIET NAM & YEMEN. .
Description
During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.
Product
HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.
Manufacturer(s)
HemoCue AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →