Recall Z-1834-2013 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only.
| Date | Jul 31, 2013 (initiated Jun 3, 2013) |
| Status | Terminated |
| Reason | The recall was initiated because Beckman Coulter has identified a software error on AU5800 analyzers with the Automation Ready (AR) Sampler Kit. This software error results in the failure of the concentrated wash solution pump to stop, creating an overflow or leak on each analyzer unit. |
| Root cause | Software design |
| Action | An Urgent Product Correction letter dated 5/29/13 was sent on the week of June 3, 2013 to all the customers who received the AU5800 Clinical Chemistry Analyzer with Automation Ready (AR) Connection (All Software versions). The letter informed the customers of the problem identified and the actions to be taken. Customers were instructed to complete and return the enclosed Response Form within 10 days and to share the information with their laboratory staff. Customers with questions are instructed to contact the 24 hours Call Center (Hotline) at (800) 854-3633 in the US and Canada. |
| Quantity | 76 units |
| Distribution | Worldwide Distribution, including Nationwide (US) and the countries of China, Italy, Japan, Canada, Turkey, United Kingdom, Singapore, Israel, and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112412 | AU5800(R) CHEMISTRY ANALYZER Beckman Coulter, Inc., Dec 23, 2011 |