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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2190-2013

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.

Publicado el 18 de septiembre de 2013 · Inicio del retiro: 15 de julio de 2013

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
HemoCue AB
Distribuidor
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. .
Lote
Model #, 110705, Lot #, 1207767, 1208500; 1208501; 1208772; 1208773; 1208775; 1208777-1208781; 1208787; 1208788; 1208794; 1208795; 1209513-1209517; 1209527-1209531; 1209539; 1209540; 1209546; 1209547; 1210550; 1210551; 1210556-1210558; 1210560; 1210570-1210574; 1210581-1210583; 1210587; 1210590; 1210591; 1211599; 1211602-1211605; 1211608; 1211611; 1211614; 1211616; 1211618; 1211621; 1211623; 1211626; 1211627; 1211635; 1211636; 1211646-1212649; 1212654; 1212655; 1212659; 1212676-1212680; 1212687-1212689; 1212691-1212695; 1301702-1301705; 1301712; 1301713; 1301723-1301725; 1301733-1301735; 1302761-1302763; 1302768; 1302776; 1302777; 1303504-1303508; 1303517; 1303518; 1303522-1303524; 1303785-1303787; 1303794; 1303796; 1303797 & 1304534-1304537. Model #, 110717, Lot #, 1208503; 1208785; 1208786; 1208789; 1208790; 1208796; 1208797; 1208798; 1209504 - 1209510; 1209518-1209521; 209526; 1209533; 1209534; 1209537; 1209541; 1210552; 1210553; 1210559; 1210561; 1210569; 1210575-1210579; 1210584-1210586; 1210589; 1210600; 1211598; 1211601; 1211606; 1211609; 1211610; 1211617; 1211619; 1211620; 1211628-1211630; 1211639-1211642; 1212650-1212652; 1212671-1212673; 1212681-1212685; 1212696; 1212698; 1212699; 1301709-1301711; 1301716-1301719; 1301722; 1301726-1301729; 1301732; 1302754-1302756; 1302766; 1302767; 1302771-1302773; 1302778-1302781; 1303500-1303502; 1303509-1303513; 1303519-1303521; 1303782; 1303788-1303792; 1303798; 1303799; 1304526- 1304531 & 1304542-1304544. Model #, 110718, Lot #, 1208502; 1208782-1208784; 1208792; 1208793; 1208799; 1209511; 1209512; 1209522; 1209523; 1209532; 1209535; 1209536; 1209538; 1209542; 1209544; 1209545; 1210554; 1210555; 1210562-1210568; 1210580; 1210592-1210596; 1211607; 1211612; 1211622; 1211631-1211633; 1211643-1211645; 1212653; 1212674; 1212675; 1212686; 1212700; 1212701; 1301706; 1301708; 1301714; 1301715; 1301720; 1301721; 1301730; 1301731; 1302759; 1302760; 1302764; 1302765; 1302774; 1303503; 1303514-1303516; 1303525; 1303783; 1303784; 1303793; 1304532; 1304533 & 1304539-1304541. Model #, 110721, Lot #, 1210555
Clasificación de riesgo
Class II
Área (FDA)
device
País
Sweden

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