22
Dec
1999

Chiron IVD Analyzer Class II

0

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.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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