Hematology diluents recalled over elevated platelet background check counts
Beckman Coulter is recalling 76,098 units of COULTER DxH Diluent and DxH ECO Diluent because specific lots contribute to elevated platelet Daily Checks background 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 2/5 (Moderate).
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: Scored 2 because the record's stated consequence is an elevated background count on a daily instrument check, with no patient result error or reported harm.
Plain-English summary
COULTER DxH Diluent, REF 628017, and COULTER DxH ECO Diluent, REF C67250, are being recalled by Beckman Coulter, Inc. The record describes the product as an isotonic buffered diluent for use in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on UniCel DxH Coulter Cellular Analysis Systems, and as a rinsing agent.
The reason given in the enforcement record is that specific lots of diluents contribute to elevated platelet Daily Checks background counts cycle with use with analyzers.
The record lists 76,098 units, of which 61,843 are in the US and 14,255 outside it, under UDI-DI 15099590233686, with lot numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across the states listed in the record. The FDA has classified the action as Class II.
The stated consequence in the enforcement record is an elevated background count on the analyzer's daily check, and no injuries are reported. Laboratories should follow Beckman Coulter's instructions.
The recalled product
- Product
- COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on…
- 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 (1)
- Catalog Numbers: COULTER DxH Diluent
Distribution
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