Recall Z-0216-2026
Beckman Coulter, Inc. · initiated September 19, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Codes / lots: C11137 UDI-DI: 15099590732103; Serial Numbers: 300621 300655 300564 300572 300411 300425 300576 300577 300625 300295 300713 300714 300289 300497 300333 300520 300524 300440 300443 300441 300444 300445 300528 300515 300332 300466 300484 300412 300395 300541 300255 300270 300499 300435 300436 300467 300532 300560 300600 300604 300605 300607 300609 300610 300707 300709 300710 300596 300597 300374 300679 300677 300558 300559 300593 300584 300169 300239 300124 300225 300595 300638 300495 300496 300381 300668 300237 300156 300571 300641 300131 300637 300488 300142 300141 300143 300151 300152 300316 300546 300298 300299 300328 300414 300413 300422 300132 300534 300317 300318 300567 300568 300163 300162 300276 300277 300174 300226 300370 300459 300386 300503 300388 300389 300745 300742 300204 300216 300247 300246 300438 300149 300662 300716 300268 300380 300391 300429 300437 300303 300305 300349 300353 300290 300301 300243 300220 300166 300176 300188 300269 300273 300144 300398 300229 300721 300722 300199 300200 300309 300632 300602 300601 300314 300177 300224 300669 300628 300291 300223 300456 300719 300718 300410 300547 300450 300649 300116 300171 300368 300145 300250 300288 300331…
Reason for recall
Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.
FDA-determined cause: Software design
Action taken
An URGENT MEDICAL DEVICE RECALL notification letter dated 9/12/25 was sent to customers. " When ordering tests for a manually diluted sample through the Test Order Entry page, a unique sample ID is required. " Alternatively, use the Dilute and Rerun feature or an automated dilution to measure diluted samples. Refer to Rerunning a Test with a Diluted Sample in the System Help for more information. " Beckman Coulter suggests sharing this letter with your Medical Director to determine if performing a retrospective review of results is necessary. " Beckman Coulter is investigating the root cause of this issue and will implement a correction with a future software release. " Your Beckman Coulter service representative will contact you to schedule the software upgrade 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 Customer Support Center: " From our website: http://www.beckmancoulter.com
Details
- Recall number
- Z-0216-2026
- Initiated
- September 19, 2025
- Posted by FDA
- October 21, 2025
- Product code
- JLW – Radioimmunoassay, Thyroid-Stimulating Hormone
- Quantity
- 571 units
- Distribution
- Worldwide - US Nationwide distribution.
- Recalling firm
- Beckman Coulter, Inc., Chaska, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0215-2026 Class II | DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number…Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i… | 09/19/2025Open, Classified |