AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and ot
FDA device recall Z-1430-2013 · posted 2013-05-29 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determined that the tubing/joint connections associated with these MODs may leak concentrated detergent. Beckman Coulter has received complaints that the joint connecting the tubing appears to disintegrate over time, causing a leak.
- Action taken
- Beckman Coulter sent an Urgent Product Correction letter on April 26, 2013 along with a response form. The letter notified customers of the product, problem, and actions to be taken by the customers. Contact the Call Center at 800-854-3633 for questions regarding this notice.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 108 units
- Distribution
- Worldwide Distribution-USA Nationwide and countries of: AU, CA, DE, ES, GB, IT, PT, and JP.
- Date initiated
- 2013-04-26
- Date posted
- 2013-05-29
- Date terminated
- 2014-08-04
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER (K011720) | Olympus America, Inc. | 2001-06-25 |
| MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER (K003721) | Olympus America, Inc. | 2000-12-18 |