Beckman Coulter Recalls LH Series Diluent Due to Cuvette Compromise Risk
Beckman Coulter is recalling LH Series Diluent because it may eventually compromise the Hgb cuvette in LH 750 and LH780 Hematology Systems.
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 and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Beckman Coulter Inc. is recalling the COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. This diluent is used in LH 750 and LH780 Hematology Systems to analyze portions of diluted blood samples for different blood cell types, such as red blood cells and platelets.
The recall is being conducted because the use of the affected diluent lots may eventually result in a compromised Hgb cuvette. The affected lot numbers are 510376F-510657F and M405229-M503553.
A total of 409,042 units were distributed, with 339,545 units distributed in the United States. Distribution was nationwide, including Puerto Rico and the U.S. Virgin Islands, as well as in Bermuda, Canada, Guatemala, Hong Kong, Mexico, Panama, Taiwan, and Trinidad-Tobago. Users of these systems should stop using the affected diluent lots and contact Beckman Coulter for further instructions.
The recalled product
- Product
- COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Numbers: 510376F-510657F
- M405229-M503553.
Distribution
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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