Recall Z-1704-2017— Beckman Coulter Inc.

Name: FDA recall Z-1704-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-13

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2017-02-13, terminated 2017-04-12. It names 2 FDA 510(k) clearances: K112412, K961274. Product: Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the AU5800 Clinical Chemistry Analyzers are an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and ion selective electrode.. Reason: Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-02-13
Terminated: 2017-04-12
Firm location: Brea, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K112412 — AU5800(R) CHEMISTRY ANALYZERBeckman Coulter, Inc.·cleared 2011-12-23
K961274 — OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZEROlympus America, Inc.·cleared 1996-07-05

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 Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the AU5800 Clinical Chemistry Analyzers are an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and ion selective electrode.

Reason for recall

Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match.

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