Beckman Coulter Recalls Coulter DxH Diluent Due to Elevated Platelet Background Counts
Beckman Coulter is recalling Coulter DxH Diluent because it may cause elevated platelet background counts, resulting in failed Daily Checks on specific Coulter Cellular Analysis Systems.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a functional defect (failed Daily Checks) without reporting any patient injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Beckman Coulter Inc. is recalling Coulter DxH Diluent, Catalog No. 628017. The product is a solution used to dilute whole-blood samples for the analysis of different blood cell types and the measurement of hemoglobin.
The recall is being issued because the diluent may be associated with elevated platelet (PLT) background counts between 3-7 x 10(3) cells/uL. This issue will result in failed Daily Checks on the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems.
A total of 46,050 units were distributed, with 40,078 units in the United States. The product was distributed nationwide in the US and internationally to Canada, Chile, Mexico, Panama, and Thailand. The affected lot numbers are 3510470, 3510480, 3510490, 3510500, 3510510, 3510520, 3510530, 3510540, 3510550, 3510570, 3510580, 3510590, 3510600, 3510610, 3510620, 3510630, and 3510690.
The recalled product
- Product
- Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types and the measurement
- 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 (17)
- Lot No. 3510470
- 3510480
- 3510490
- 3510500
- 3510510
- 3510520
- 3510530
- 3510540
- 3510550
- 3510570
- 3510580
- 3510590
- 3510600
- 3510610
- 3510620
- 3510630
- 3510690.
Distribution
Distributed nationwide across the United States.
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