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.