IMMULITE Immunoassay Analyzer Class II 334 units

All IMMULITE 2000 Automated Immunoassay Analyzers with SoftwareVersion 1.1, a clinical automated immunoassay analyzer intended
for in-vitro diagnostic use for detection of analytates in human
specimens. Recall #Z-909-9.

REASON

If the initial counts of the reaction tubes are exactly 10,000
cps, this leads to erroneously low calculated results.

CODE

All serial numbers in commercial distribution (Note: The recall
product was initially released with Software Version 1.1 on March
2, 1998).

MANUFACTURER

DPC Cirrus, Inc., a subsidiary of Diagnostic Products
Corporation, Randolph, New Jersey.

RECALLED BY

Manufacturer, by telephone March 2 & 3, 1999, and by Technical
Bulletins dated March 2 and 3, 1999. Firm-initiated field
correction complete.

DISTRIBUTION

Nationwide and international.

QUANTITY

334 units were distributed.

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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