DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
FDA device recall Z-1926-2025 · posted 2025-06-06 · Open, Classified
Recall details
- Recalling firm
- Beckman Coulter, Inc.
- Reason for recall
- A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
- Action taken
- An "URGENT MEDICAL DEVICE RECALL (UMDR)" notification letter dated 4/16/25 was sent to customers. ACTION: If your laboratory encounters the system event described in this letter: Perform a system initialization to resume normal operation. Repeat testing for any canceled tests. No action is required if your laboratory has not observed the system event listed above. RESOLUTION: Beckman Coulter will release a modification for this issue. Your service 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 Customer Support Center: From our website: http://www.beckmancoulter.com
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- JLW
- Quantity affected
- 324 units
- Distribution
- Worldwide distribution: US (Nationwide) and OUS Global (Foreign) to countries of: Italy, Germany, Spain, New Zealand, France, Australia, Slovakia, Switzerland, Ireland, Brazil, Taiwan, Province of Chi
- Date initiated
- 2025-04-23
- Date posted
- 2025-06-06
- Location
- Chaska, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer (K221225) | Beckman Coulter, Inc. | 2022-11-10 |