Beckman Coulter, Inc.: DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide. Quantity: 451 systems Lot/code info: UDI-DI: 15099590369194; Serial Numbers: 609821 609831 609741 609746 608191 608200 608327 609460 609461 609468 609703 609762 608186 609046 609047 609095 609096 608992 608993 608999 608998 609766 609331 609358 609185 609182 609317 609760 609081 609084 609125 609325 609213 609227 609161 609109 609111 609230 609316 609799 609451 609617 609698 609689 609813 608375 608355 609805 609804 608357 608366 609112 609124 609156 608259 609693 609694 609260 609553 609552 608367 609838 609515 609324 609330 609662 609767 609786 609078 609718 609719 608125 609181 609166 608211 609374 609359 608249 609007 606845 609757 609758 609065 609063 609549 609548 609237 609443 609394 608354 608356 609546 609733 609648 609653 609202 609201 609505 609734 608245 609738 609737 609234 609235 608148 608149 608153 608336 608376 609228 609229 609442 609514 609544 609545 609659 609656 609658 609655 609798 609817 609186 609128 609214 609162 609155 608187 609064 609066 609547 609550 609551 609652 609647 609657 609654 606065 606441 603736 608218 608250 609375 609386 609387 609393 609787 609679 609690 609489 609808 609837 609239 609261 605840 609036 609615 609614 609035 609129 609661 609660 609663 608132 609691 609697 609832 609449 609504 609110 609189 609190 609080 609079 609176 609236 609238 605066 609231 609232 608206 609446 609447 609448 609412 609311 609310 609811 609822 609488 609814 609816 609522 609523 609542 609749 609747 610231 610244 610166 610178 610185 610770 609968 610707 610844 610542 610448 610163 6101

UPC codes

15099590369194

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.