Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
FDA device recall Z-2414-2024 · posted 2024-07-23 · Open, Classified
Recall details
- Recalling firm
- Beckman Coulter, Inc.
- Reason for recall
- The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed patient results.
- Action taken
- Letters dated 5/29/2024 were issued via email and postal mail on 6/4/2024. The letter described the issue, the impact, and the action which was that the consignee's Beckman Coulter service representative will contact the consignee to replace parts affected by the issue. The firm will replace all affected USB 2.0 cables. The information in the letter is to be shared with the consignees laboratory staff and if the device has been forwarded to another laboratory, the consignee is requested to send them a copy of the letter. The consignee is requested to respond to the letter within 10 days either via email or by manually completing the enclosed Response Form.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- JJE
- Quantity affected
- 143 devices
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, IN, KS, NH, PA, and TX. The countries of Australia, Austria, Belgium, Brazil, Croatia, Czechia, Egypt, France, Germany, Hungary, Ireland, Is
- Date initiated
- 2024-06-04
- Date posted
- 2024-07-23
- Location
- Chaska, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer (K221225) | Beckman Coulter, Inc. | 2022-11-10 |