Recall Z-1873-2013— Beckman Coulter Inc.

Name: FDA recall Z-1873-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-26

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2012-10-26, terminated 2013-10-18. It names one FDA 510(k) clearance: K112412. Product: Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC), material and other accessories.. Reason: Beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling on the diluted detergent tank to show the proper disposition of the on/off valve..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-10-26
Terminated: 2013-10-18
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K112412 — AU5800(R) CHEMISTRY ANALYZERBeckman Coulter, Inc.·cleared 2011-12-23

K-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

Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC), material and other accessories.

Reason for recall

Beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling on the diluted detergent tank to show the proper disposition of the on/off valve.

Data sourced from openFDA. This site is unofficial and independent of the FDA.