HemoCue¿ Urine Albumin Microcuvettes — Class II medical device recall Z-0086-2014
Terminated recall by HemoCue AB, reported 2013-11-06, distributed nationwide. HemoCue AB has become aware of a production related problem involving punctured HemoCue¿ Urine Albumin Microcu
| Recall number | Z-0086-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | HemoCue AB, Angelholm, N/A, Sweden |
| Recall initiated | 2013-07-16 |
| Classified | 2013-10-25 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2014-04-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BH, CA, CZ, DE, DK, ES, FI, FR, GB, HK, ID, IN, IT, KE, KR, MX, NG, NO, PL, QA, RO, SE, TW, UA, ZA |
| Lot numbers | 1208848, 1208849, 1208850, 1208851, 1208853, 1208854, 1209855, 1209856, 1209857, 1209858, 1209860, 1209862, 1210863, 1210864, 1210865, 1210866, 1210867, 1210868, 1210869, 1210870, 1210871, 1210872, 1210873, 1211874, 1211875, 1211876, 1211877, 1211878, 1211879, 1211880, 1211881, 1212883, 1212884, 1212885, 1212886, 1212887, 1212888, 1212889, 1301802, 1301803 and 37 more |
| Model numbers | 110608, 110610, 110611, 110613, 110615, 110616 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0086-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.