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U.S. Department of Health and Human Services

Class 2 Device Recall HemoCue Glucose 201 Microcuvettes

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 Class 2 Recall
HemoCue Glucose 201 Microcuvettes
see related information
Date Posted September 11, 2013
Recall Status1 Open
Recall Number Z-2190-2013
Recall Event ID 65854
Premarket Notification
510(K) Number
K020935 
Product Classification Glucose Oxidase, Glucose - Product Code CGA
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.
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
Recalling Firm/
Manufacturer
HemoCue AB
Kuvettgaten 1
Angelholm
For Additional Information Contact Mr. Shane T. Hawes
440-925-3485
Manufacturer Reason
for Recall
During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging
Action HemoCue sent an Urgent Field Safety Notice dated July 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine any affected product and Return the Field Safety Notice Verification Form to e-mail: 2013glufsn@hemocue.com or fax 562-668-5794 Customers would be contacted to coordinate return and replacement of the affected microcuvettes. Customers with questions were instructed to call 800-426-7256. For questions regarding this recall call 440-925-3485.
Quantity in Commerce 22,215 boxes of 100 cuvettes distributed in US, 34, 841 distributed outside the US
Distribution 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. .
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CGA and Original Applicant = HEMOCUE, INC.
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