—#214698

Product

DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K023764
Affected lot / code info: UDI-DI: 15099590369224; Serial Numbers: 902515 902070 902390 902369 902429 902529 902598 902597 902275 902291 902339 902502 902278 902283 902329 902340 902528 902534 902392 902526 902527 902248 902249 902523 902522 902225 902524 902586 902427 902424 902505 902455 902413 902414 901697 902578 902579 902303 902264 902265 902428 902089 902227 902226 902228 902229 902256 902257 902075 902323 902197 902231 902270 902271 902301 902305 902273 902362 902342 901898 902545 902383 902530 902531 902416 901890 902581 902318 902316 902317 902454 902453 902451 902504 902514 902525 902535 902274 902102 902224 902356 902566 902223 902404 902307 902306 902083 902085 902328 902351 902350 902434 902433 902516 902518 902322 902391 902204 902415 902292 902294 902378 902379 902382 902334 902335 902532 902222 902365 902326 902327 902425 902293 902420 902419 902418 902246 902555 902558 902564 902588 902421 902432 902244 902245 902363 902364 902260 902290 902296 902519 902521 902559 902478 902456 902457 902549 902554 902435 902450 902253 902254 902582 902583 902352 902353 902357 902360 902361 902399 902547 902596 902252 902393 902398 902405 902426 902368 902412 902492 902281 902219 902220 902511 902610 902635 902625 902614 902615 902621 902620 902634 902609 902606 902601 902603 902604

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

An URGENT MEDICAL DEVICE RECALL notification dated 6/25/25 was sent to customers. ACTION: If your laboratory encounters any of the events described in this letter: " Perform a system initialization to resume normal operation. o If repeated initialization attempts fail, contact Customer Technical Support. " Repeat testing for any cancelled tests. " No action is required if your laboratory has not observed the events listed above ESOLUTION: "A Beckman Coulter representative will schedule the modification installation when it is available. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: " Electronically, if you received this communication via email. " Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact our Customer Support: " From our website: http://www.beckmancoulter.com

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 1000 Lake Hazeltine Dr, Chaska, Minnesota 55318-1037

Distribution

Distribution pattern: Worldwide distribution - US Nationwide.

Timeline

Recall initiated: 2025-06-25
Posted by FDA: 2025-08-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #214698. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.