COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells

FDA device recall Z-2138-2023 · posted 2023-07-12 · Open, Classified

Recall details

Recalling firm

Beckman Coulter, Inc.

Reason for recall

Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.

Action taken

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 management to determine whether a retrospective review of results is necessary.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GIF

Quantity affected

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, P

Date initiated

2023-05-31

Date posted

2023-07-12

Location

Miami, FL