Beckman Coulter Recalls LH 750 Hematology Analyzers Due to Optical Degradation
Beckman Coulter is recalling LH 750 Hematology Analyzers because optical degradation may delay reporting results for specific blood cell counts.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a delay in reporting diagnostic results, which is a risk-of-harm product issue where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Beckman Coulter Inc. is recalling the Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570. This device is a quantitative, automated hematology analyzer and leukocyte differential counter used for in vitro diagnostic purposes in clinical laboratories. It provides automated reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs), red blood cells (RBCs), and white blood cells (WBCs) in body fluids.
The recall is being conducted because optical degradation in the device may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), white blood cell differential, and/or reticulocytes. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
A total of 4,155 units are involved in the recall, with 1,676 units distributed in the United States. The remaining units were distributed worldwide to numerous countries including 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. Clinical laboratories should contact Beckman Coulter for instructions on how to proceed with the recall.
The recalled product
- 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…
- Manufacturer
- Beckman Coulter Inc.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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