Recall Z-0974-2012 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
AU Clinical Chemistry Analyzers: Model Number: AU400 Clinical Chemistry Analyzer, AU400(e) Clinical Chemistry Analyzer, AU480 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
| 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 |