Reported Nov 6, 2013 · Terminated
HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid,…
HemoCue AB
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: HemoCue AB · Kuvettgaten 1 · Angelholm, N/A · N/A
Is this the product you have?
- 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
- Lot codes and dates
12 of 12 products
Products covered by this recall Model / number Barcodes Product as published 110608— — Lot Number: 1210865, 1210873, 1211878, 1301893, 1302810, 1303836, 1304838, 1304840 and 1304842. 110610— — Lot Number: 1209857, 1210870, 1211874, 1211879, 1212885, 1301803, 1301893, 1302817 and 1302818. 110611— — 13028141302815Lot 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. 110613— — Lot Number: 1303825 110615— — Lot Number: 1209858, 1211878 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. - Amount recalled
- 10,356 boxes/50 microcuvettes
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
HemoCue AB has become aware of a production related problem involving punctured HemoCue¿ Urine Albumin Microcuvettes single pack pouches.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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