Recall Z-0176-2015— Beckman Coulter Inc.
Class II · Terminated
Class II FDA medical device recall by Beckman Coulter Inc., initiated 2014-10-06, terminated 2015-06-29. It names one FDA 510(k) clearance: K060256. Product: UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.. Reason: Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the DxC 600i analyzer because it may experience a "MFC Exception" error during normal operation of the analyzer system..
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-06
- Terminated
- 2015-06-29
- Firm location
- Brea, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.
Reason for recall
Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the DxC 600i analyzer because it may experience a "MFC Exception" error during normal operation of the analyzer system.
Data sourced from openFDA. This site is unofficial and independent of the FDA.