FDA (Devices) recall action 97730
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Beckman Coulter is recalling 657 UniCel DxI 800 analyzers because defective gantry sub-components can cause a z-axis motion error that halts the analyzer and delays results.
Beckman Coulter is recalling 80 UniCel DxI 600 analyzers because defective gantry sub-components can cause a z-axis motion error that halts the analyzer and delays results.