21
Aug
2002

Inc Class II Dade Behring

0

Company: Dade Behring, Inc
Date of Enforcement Report: 8/21/02
Class: II

PRODUCT
Dimension(R) Xpand software revision 6.0.1 and 6.1 (Clinical Chemistry Analyzer). Recall # Z-1226-2.

REASON
The sample probe does not accurately track the fluid level.

CODE
Xpand software revision 6.0.1 and 6.1.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Dade Behring, Inc., Newark, DE, by telephone on May 11, 2002.
Manufacturer: Dade Behring, Inc., Brookfield, CT.
Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
261.

DISTRIBUTION
Nationwide.

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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