Class 2 Device Recall UniCel DxI 800 Access Immunoassay Analyzer

• Date Initiated by Firm: June 25, 2025
• Date Posted: August 05, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2266-2025
• Recall Event ID: 97162
• 510(K)Number: K023764
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100
• Code Information: 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 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• FEI Number: 2122870
• Recalling Firm/ Manufacturer: Beckman Coulter, Inc.; 1000 Lake Hazeltine Dr; Chaska MN 55318-1037
• For Additional Information Contact: Ian Pilcher; 952-448-4848
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: 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
• Quantity in Commerce: 2203 systems
• Distribution: Worldwide distribution - US Nationwide.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JJE