Medical Blood Cell Diluent Recalled for Out-of-Specification Parameters
Beckman Coulter is recalling specific lots of COULTER DxH Diluent due to out-of-specification conductivity, osmolality, and pH. The diluent may produce inaccurate blood cell test results.
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: Class II recall of a diagnostic reagent with specification deviations that could affect test accuracy. No injuries reported, but the defect poses risk to diagnostic accuracy in a critical medical application.
Plain-English summary
Beckman Coulter, Inc. is recalling specific lot numbers of COULTER DxH Diluent (REF 628017), a medical device used for counting and sizing blood cells. The product was distributed worldwide to the United States and multiple countries including Argentina, Bolivia, Brazil, Canada, Chile, Colombia, Ecuador, Hong Kong, Indonesia, Kuwait, Mexico, Panama, Peru, Puerto Rico, Taiwan, Trinidad and Tobago, Uruguay, and Vietnam.
Certain lot numbers beginning with 3541, 3542, 3543, or 3544 were found with conductivity, osmolality, and pH values outside manufacturing specifications. These parameters are critical for proper diluent function in blood cell analyzers.
Healthcare facilities and laboratories with affected lot numbers should discontinue use and contact Beckman Coulter for replacement products and guidance. Out-of-specification diluent may produce inaccurate blood cell counts, which could affect clinical diagnostic and treatment decisions.
The recalled product
- Product
- COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
- Manufacturer
- Beckman Coulter, Inc.
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 (20)
- UDI DI 150995901HEMDILUENT5R
- 3541510
- 3541520
- 3541550
- 3541610
- 3541620
- 3541670
- 3541690
- 3541750
- 3541770
- 3541790
- 3541810
- 3541830
- 3541860
- 3541880
- 3541900
- 3541910
- 3541920
- 3541930
- 3541940
Distribution
Distributed nationwide across the United States.
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