FDA Medical devices recall ·
UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100 recall
- Recall number
- Z-2266-2025
- 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
- 2203 systems
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100
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: 15099590265373; Serial Numbers: 608114 608209 609132 609163 608344 608113 608233 609224 609218 609221 609070 609071 609117 608164 609591 609692 608197 609534 609455 609524 609319 609062 609094 609452 609750 609801 609686 609198 609644 609518 609745 609496 608387 609183 609188 609699 609735 609618 609492 609028 609583 609765 609790 609187 605528 609137 609157 609226 608242 608243 609191 609527 609256 608996 609003 609327 609262 609264 609294 609321 609329 609265 609290 609397 609521 609320 608106 609373 608386 608389 609372 609846 609153 609241 609498 609519 609520 609744 609704 609491 609802 609810 609807 609806 608234 609286 609739 609824 609270 609103 609643 609641 609123 609192 609093 609499 609497 609429 609410 608994 609122 608247 609334 607653 609849 609100 609101 609370 608391 608362 609371 609136 609195 608264 608265 607196 609784 609494 609223 609526 609220 608347 609197 609099 609098 609097 609576 609285 609225 609626 609640 609150 609233 609803 609283 609322 609537 609318 609827 609462 609180 609408 609244 609754 609795 609791 609797 609800 609789 609532 609531 609538 609539 609543 609541 609599 609338 608256 609323 609536 608346 609833 606661 608388 609001 609246 608393 609369 609535 609031 609092 609582 609834 604083 609740 609513 609210 609378 608188 609017 609018 609005 608172 609030 609385 609649 609053 609263 609184 608176 608238 609209 609020 608385 608384 608382 608276 608202 608997 609023 608205 609004 609102 609016 608175 609015 608171 609019 6082
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-2266-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.