Z-2190-2013 Class II Terminated
FDA device recall Z-2190-2013 was initiated by HemoCue AB on July 15, 2013 and is designated Class II. Reason for recall: During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches. The recall status is terminated (terminated September 2, 2014). Affected quantity: 22,215 boxes of 100 cuvettes distributed in US, 34, 841 distributed outside the US.
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2013
- Initiation Date
- July 15, 2013
- Termination Date
- September 2, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,215 boxes of 100 cuvettes distributed in US, 34, 841 distributed outside the US
Product Description
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.
Reason for Recall
During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.
Distribution Pattern
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. .
Code Information
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