Recall Z-2138-2023 ยท GIF Diluent, Blood Cell
Beckman Coulter, Inc.
COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
| Date | Jul 12, 2023 (initiated May 31, 2023) |
| Status | Open, Classified |
| Reason | Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications. |
| Root cause | Under Investigation by firm |
| Action | Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice on 05/31/2023 by email and mail. The notice explained the issue, its impact on the patient, and requested the following actions be taken: "Inspect the lot number set up on your instrument(s) and your current inventory with the corresponding container number (see Appendix A). Locate the container number on your diluent reagent 2D or Linear barcode label (see Appendix B). Contact Beckman Coulter Customer Technical Support Organization to replace the affected containers in your current inventory. Consult with your laboratory managem |
| Quantity | 335, 448 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Bolivia (Plurinational State of), Brazil, Canada, Chile, Colombia, Ecuador, Hong Kong, Indonesia, Kuwait, Mexico, Panama, Peru, Puerto Rico, Taiwan, Trinidad and Tobago, Uruguay, and Viet Nam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.