CLASS II ONGOING Device recall · Reported 13 Aug 2025 · FDA Enforcement Report
DxI 600 Access Immunoassay Analyzer W/Spot recalled by Beckman Coulter
Beckman Coulter is recalling DxI 600 Access Immunoassay Analyzer W/Spot B, distributed nationwide in the US. The recall was initiated on 25 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2271-2025
- FDA event ID
- 97162
- Recalling firm
- Beckman Coulter, Chaska, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Jun 2025
- FDA classified
- 5 Aug 2025
- Reported
- 13 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 25 Jun 2025 | Recall initiated by company | |
| 5 Aug 2025 | Classified by FDA | +41 days |
| 13 Aug 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
Where it was distributed
Worldwide distribution - US Nationwide.
Questions about this recall
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.
Which lots are affected?
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
Where was it sold?
Worldwide distribution - US Nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 97162This product is part of a recall event; the main page for the event is DxI 800 Access Immunoassay Analyzer W/Dual Gantry recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | DxI 800 Access Immunoassay Analyzer W/Dual Gantry recalled | Beckman Coulter | Device Malfunction | Nationwide | |
| CLASS II | DxI 800 Access Immunoassay Analyzer W/Spot recalled by Beckman Coulter | Beckman Coulter | Device Malfunction | Nationwide | |
| CLASS II | DxI 600 Access Immunoassay Analyzer W/Dual Gantry recalled | Beckman Coulter | Device Malfunction | Nationwide | |
| CLASS II | UniCel DxI 600 Access Immunoassay Analyzer recalled by Beckman Coulter | Beckman Coulter | Device Malfunction | Nationwide | |
| CLASS II | UniCel DxI 800 Access Immunoassay Analyzer recalled by Beckman Coulter | Beckman Coulter | Device Malfunction | Nationwide |
More recalls from Beckman Coulter
All 334| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US) recalled | Beckman Coulter | Other | Nationwide |
| Device | CLASS II | REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) recalled | Beckman Coulter | Other | Nationwide |
| Device | CLASS II | Access Total T4 Calibrator recalled by Beckman Coulter | Beckman Coulter | Other | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,661| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | McKesson Consult hCG Urine Cassette recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | CLASS II | Systems/units containing affected recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | CLASS II | Vitek 2 Ast-N461 Test Kit, Gram Negative Susceptibility recalled | Biomerieux | Other | MO |
| Device | CLASS II | DASH Rapid PCR Instrument recalled by Nuclein | Nuclein | Device Malfunction | Nationwide |