Beckman Coulter, Inc.: Medical Device Recalls in 2023

According to to data from the FDA, there were 12 medical device recalls made by Beckman Coulter, Inc. in 2023. See the details of the recalls below.

You can see similar recalls for other firms.

• Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
• DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
• Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
• iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325
• UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
• DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
• COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
• BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
• Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
• Access Thyroglobulin Calibrators
• Ringed DxI Reaction Vessels (RVs)
• DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic