15
Oct
2003

DPC Cirrus Class III

0

Company: DPC Cirrus
Date of Enforcement Report: 10/15/03
Class: III

PRODUCT
Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software. Recall # Z-1138-03.

REASON
Version 2.6 software was released however, it will not properly handle adjustment slopes.

CODE
All units.

RECALLING FIRM/MANUFACTURER
DPC Cirrus, Flanders, NJ, by Recall Technical Bulletins on June 13, 2003. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
434 upgrades.

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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