FDA Medical devices recall ·
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460 recall
- Recall number
- Z-2271-2025
- Date
- (initiated June 25, 2025)
- Company / brand
- Beckman Coulter, Inc.
1000 Lake Hazeltine Dr, Chaska, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 177 systems
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
Worldwide distribution - US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2271-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.