Chiron IVD Analyzer Class II

REASON

Software may incorrectly link previous assay results to a
different patient ID.

PRODUCT

Chiron Diagnostics Automated Chemiluminescence System, Model

ADVIA:CENTAUR for the quantitative determination of various in
vitro diagnostic assays using direct chemiluminescent technology.

Recall #Z-358/359-0.

CODE

Catalog Numbers: 114564, 572561, 572562, 572563, 572564,
and 572566. All ADVIA:Centaur Immunoassay Analyzers with
software
versions 2.01 and 2.11.

MANUFACTURER

Bayer Corporation, Oberlin, Ohio.

RECALLED BY

Manufacturer, by customer bulletin on December 22, 1999.

Firm-initiated field correction ongoing.

DISTRIBUTION

Nationwide and international.

QUANTITY

660 units.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.