Home / Recalls / Medical Devices
HemoCue AB recalls HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidim
Recalled November 6, 2013 · FDA recall Z-0086-2014 · HemoCue AB
Hazard
HemoCue AB has become aware of a production related problem involving punctured HemoCue¿ Urine Albumin Microcuvettes single pack pouches. · FDA Class II
Units
10,356 boxes/50 microcuvettes
Sold at
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.
Description
HemoCue AB has become aware of a production related problem involving punctured HemoCue¿ Urine Albumin Microcuvettes single pack pouches.
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
Manufacturer(s)
HemoCue AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →