Recall Z-0084-2027 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
| Date | Oct 2, 2026 (initiated Sep 2, 2026) |
| Status | Open, Classified |
| Reason | Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to revert the test units to the system default setting without notifying the user. The system does Pre-Review Reminders Include OII and CDRHRecallGroup@fda.hhs.gov in any discussions on change/elevation of recalls to Class I classification and s |
| Root cause | Software design |
| Action | On September 2, 2026, the firm began notifying customers via letters titled "URGENT MEDICAL DEVICE RECALL." Customers were instructed to inform their laboratory or medical director to assess laboratory and patient impact. For analyzers on software versions earlier than 1.5: - Users should verify that their instrument displays the intended units in the Test Menu page within the System Configuration page prior to reporting patient results. - Recall letter should be posted on or near affected analyzers if they have the affected software version. This issue is resolved in software version 1.5 |
| Quantity | 146 US, 170 OUS |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220977 | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd., Jul 20, 2023 |