HemoCue AB: HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed

Is my product affected?

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 lev

• UPC 13028141302815

Check against the official notice below — it lists the full affected range.

What happened

HemoCue AB is recalling HemoCue Urine Albumin Microcuvettes due to a production problem that caused punctures in single pack pouches. The recall affects approximately 10,356 boxes containing 50 microcuvettes each, distributed worldwide including throughout the United States and multiple countries. The affected products are identified by specific model numbers (110608, 110610, 110611, 110613, 110615, and 110616) and their associated lot numbers.

The source document does not specify what consumers or healthcare facilities should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

HemoCue AB has become aware of a production related problem involving punctured HemoCue¿ Urine Albumin Microcuvettes single pack pouches.

Details from the source

Reason for recall: HemoCue AB has become aware of a production related problem involving punctured HemoCue¿ Urine Albumin Microcuvettes single pack pouches. Distribution: 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, M Quantity: 10,356 boxes/50 microcuvettes Lot/code info: 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.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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