FDA (Devices) recall action 97162
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
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.
A DxI 600 Access Immunoassay Analyzer is being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors that could delay patient results.
DxI 800 Access Immunoassay Analyzers with Spot B are being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors. 451 systems are affected.
UniCel DxI 600 Access Immunoassay Analyzers are being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors. 271 systems are affected.
DxI 600 Access Immunoassay Analyzers with Spot B are being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors. 177 systems are affected.
UniCel DxI 800 Access Immunoassay Analyzers are being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors that could delay patient results. 2,203 systems affected.
A DxI 800 Access Immunoassay Analyzer is being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors that could delay patient results.