HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quanti...
FDA Device Recall #Z-0086-2014 — Class II — July 16, 2013
Recall Summary
| Recall Number | Z-0086-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 16, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | HemoCue AB |
| Location | Angelholm, N/A |
| Product Type | Devices |
| Quantity | 10,356 boxes/50 microcuvettes |
Product Description
HemoCue¿ 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
Reason for Recall
HemoCue AB has become aware of a production related problem involving punctured HemoCue¿ Urine Albumin Microcuvettes single pack pouches.
Distribution Pattern
Worldwide 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.
Lot / 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.
Other Recalls from HemoCue AB
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2070-2025 | Class II | The HemoCue Glucose 201 Microcuvettes are desig... | May 12, 2025 |
| Z-0101-2014 | Class II | HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/2... | Jul 25, 2013 |
| Z-2190-2013 | Class II | HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuv... | Jul 15, 2013 |
| Z-0619-2013 | Class III | Analyzing system consists of a small and portab... | Nov 7, 2012 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.