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Beckman Coulter Inc. recalls Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coulter LH 750 Hematology Analyzer
Recalled December 18, 2013 · FDA recall Z-0470-2014 · Beckman Coulter
Hazard
Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), white blood cell differential and/or reticulocytes. · FDA Class II
Units
4155 units total (1676 units in US)
Sold at
Worldwide Distribtion - USA Nationwide including the countries of Algeria, Andorra, Angola, Australia, Austria, Bahrain, Bangladesh, Belgium, Bermuda, Bosnia and Herzegovina, Bulgaria, China, Colombia, Croatia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, Virgin Islands, U.S., and Zimbabwe.
Description
Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), white blood cell differential and/or reticulocytes.
Product
Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coulter LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter¿ LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →