Recall Z-0152-2014 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
| Date | Nov 5, 2013 (initiated Sep 9, 2013) |
| Status | Terminated |
| Reason | The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, accuracy of the ISE test results may be affected. |
| Root cause | Nonconforming Material/Component |
| Action | A customer notification letter dated 9/9/13 was sent to customers who received the ISE REF Valve, Part Number MU3226 for the AU400, AU640, AU2700, AU5400 and the ISE REF Valve, Part Number MU7638 for the AU480, AU680, AU5800 Chemistry Analyzers. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Beckman Coulter Customer Support Center via http://www.beckmancoulter.com/customersupport/support, via phone at (800) 85 |
| Quantity | 4584 units total (1173 units in US) |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada, Vietnam, Zambia, and Zimbabwe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003721 | MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER Olympus America, Inc., Dec 18, 2000 |
| K011720 | OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER Olympus America, Inc., Jun 25, 2001 |
| K961274 | OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER Olympus America, Inc., Jul 5, 1996 |
| K981743 | OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER Olympus America, Inc., Jun 9, 1998 |