Recall Z-0977-2012 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
AU Clinical Chemistry Analyzers: Model Number: AU5400 Clinical Chemistry Analyzer. The AU Clinical Chemistry Analyzers are fully automated photometric analyzers intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay.
| Date | Feb 7, 2012 (initiated Jul 12, 2010) |
| Status | Terminated |
| Reason | The recall was initiated because Beckman has confirmed that the AU Clinical Chemistry Analyzers may experience cuvette overflow. |
| Root cause | Under Investigation by firm |
| Action | Beckman Coulter sent an "UPDATE TO PCA -14563: URGENT PRODUCT CORRECTION" letter dated April 27, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter is a communication which describes an alternative approach to detecting cuvette overflow. Additionally, a response form was enclosed for customers to complete and return to the firm. Contact the Customer Support Center at (800) 854-3633 or on the Beckman Coulter website at www.beckmancoulter.com/customersupport/support/default.asp for questions regarding this notificat |
| Quantity | 8225 units |
| Distribution | Worldwide Distribution-including USA (nationwide). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011720 | OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER Olympus America, Inc., Jun 25, 2001 |