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U.S. Department of Health and Human Services

Class 2 Device Recall HemoCue Urine Albumin Microcuvettes

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 Class 2 Device Recall HemoCue Urine Albumin Microcuvettessee related information
Date Initiated by FirmJuly 16, 2013
Date PostedOctober 25, 2013
Recall Status1 Terminated 3 on April 28, 2014
Recall NumberZ-0086-2014
Recall Event ID 65918
510(K)NumberK053253 
Product Classification Automated urinalysis system - Product Code KQO
ProductHemoCue Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes
Code Information Model Number 110608 Lot Number: 1210865, 1210873, 1211878, 1301893, 1302810, 1303836, 1304838, 1304840 and 1304842.  Model Number 110610 Lot Number: 1209857, 1210870, 1211874, 1211879, 1212885, 1301803, 1301893, 1302817 and 1302818.  Model Number 110611 Lot Number: 1208848, 1208853, 1208854, 1209855, 1209856, 1209858, 1209860, 1209862, 1210863, 1210865, 1210869, 1210871, 1210872, 1210873, 1211875, 1211876, 1211877, 1211880, 1211881, 1212884, 1212887, 1301802, 1301804, 1301805, 1301806, 1302811, 1302812, 1302813, 13028141302815, 1302816, 1302821, 1303823, 1303825, 1303834, 1304837, 1304839, 1304841, 1304843, 1304844, 1304845, 1304846 and 1304847.  Model Number 110613 Lot Number: 1303825  Model Number 110615 Lot Number: 1209858, 1211878  Model Number 110616 Lot Number: 1208849, 1208850, 1208851, 1210864, 1210866, 1210867, 1210868, 1210869, 1212883, 1212886, 1212888, 1212889, 1301807, 1301808, 1302809, 1303827, 1303829, 1303830, 1303831, 1303832 and 1303833.
FEI Number 3003044483
Recalling Firm/
Manufacturer		 HemoCue AB
Kuvettgaten 1
Angelholm Sweden
For Additional Information ContactMr. Shane T. Hawes
440-925-3485
Manufacturer Reason
for Recall		HemoCue AB has become aware of a production related problem involving punctured HemoCue Urine Albumin Microcuvettes single pack pouches.
FDA Determined
Cause 2		Packaging
ActionHemoCue sent an Urgent Field Safety Notice dated July 24, 2013. to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to : 1. Quarantine any HemoCue Urine Albumin (110608); lot numbers 1208848 to 1304847 you may have in your possession 2. Return the Field Safety Notice Verification Form to: fax: 562-668-5794 We apologize for the inconvenience this advisory has caused you. Please feel free to contact Technical Support at 800-426-7256 with any questions.
Quantity in Commerce10,356 boxes/50 microcuvettes
DistributionWorldwide Distribution - Nationwide Distribution including the states of AL, AR, AZ, CA, CA ,CT, FL, GA, HE, ID, IL, IN, LA, MA, ME, MI, MN, MO, MS, NC, NH, NM, NY, OH, PA, SC,TX, UT, VA, VT, WA and WI., and the countries of Australia, Bahrain, Belarus, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Hong Kong, India, Indonesia, Italy, Kenya, Lesotho, Malawi, Mauritius, Mexico, Myanmar, Nigeria, Norway, Omen, Poland, Qatar, Romania, South Africa, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Ukraine, Yemen and Zambia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KQO
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