AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry anal
FDA device recall Z-1167-2013 · posted 2013-04-24 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- Beckman Coulter, Inc. initiated this recall because there is a software error that has the potential to cause the reporting of erroneous patient results because of misidentification by the AU5800 system.
- Action taken
- Beckman Coulter sent an Urgent Product Correction letter during the week of March 18, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were informed of the software limitation and provides instructions to be taken (temporary workaround) until the software is upgraded and released. Customer contact information provided: "Call Center Hotline at 800 854-3633. New customers will receive a copy of the customer notification at the time of installation by the Field Service Personnel until revised software that corrects this issue is released.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 490
- Distribution
- Worldwide Distribution - USA, including Canada and Puerto Rico and the states of NJ, TX, CA, UT, KS, MA, NY, MI, GA, VA, IN, WI, IL, OH, NV, NC and PA. and the countries of Australia, Belgium, Czech R
- Date initiated
- 2013-03-20
- Date posted
- 2013-04-24
- Date terminated
- 2014-09-16
- 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 |
|---|---|---|
| AU5800(R) CHEMISTRY ANALYZER (K112412) | Beckman Coulter, Inc. | 2011-12-23 |