Recall Z-2138-2023— Beckman Coulter, Inc.
Class II · Ongoing
Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2023-05-31. FDA's recall record names no specific 510(k) clearance for this event. Product: COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells. Reason: Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications..
- Recalling firm
- Beckman Coulter, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-31
- Firm location
- Miami, FL, United States
Product description
COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
Reason for recall
Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.
Data sourced from openFDA. This site is unofficial and independent of the FDA.