UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with s
FDA device recall Z-2257-2012 · posted 2012-08-23 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results.
- Action taken
- The firm, Beckman Coulter, sent an "URGENT PRODUCT CORRECTION" letter dated October 13, 2011 with attached PCA Response Form to all customers who purchased the UniCel Dxl Immunoassay Systems and DxC Clinical Systems which includes all software versions. The letter describes the product, problem and actions to be taken. The customers were instructed verify the system temperatures immediately following each initialization; do not begin processing samples until this verification is complete; refer to the appendix included with the letter for detailed instructions about verifying system temperatures; review their quality control (QC) performance history; and share this information with their staff and retain this information as part of their quality system documentation, and to complete and return the enclosed response form within 10 days to Beckman Coulter, Inc., 1000 Lake Hazeltine Drive, Chaska, MN 55318; Attn: Regulatory Affairs or fax to: 1-786-639-4000. Customers with any questions regarding the notice, were instructed to contact Customer Support Center via our website, http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the US and Canada. Outside of the US and Canada, customers were instructed to contact their local Beckman Coulter Representatives.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 2442 units total (784 units in US)
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: Algeria, Angola, Argentina, Australia, Austria, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Repu
- Date initiated
- 2011-10-13
- Date posted
- 2012-08-23
- Date terminated
- 2012-08-23
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS (K042291) | Beckman Coulter, Inc. | 2004-11-12 |
| UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 (K023764) | Beckman Coulter, Inc. | 2003-01-28 |