DPC Cirrus Recalls

FDA
3
Total Recalls
1
Agencies
Nov 2004
First Recall
Jun 2006
Latest Recall

Showing 1-3 of 3 recalls

FDA

IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by DPC Cirrus Inc., Flanders, NJ 07836

The Transport Chain is used to move a Reaction Tube within the Immulite 2000. It goes on to state the error condition that occurs due to a false trip of the home sensor.

The firm became aware of the problem on 4/19 and conducted tests on 4/22/05. A service alert for field service engineers and Immulite 2000 distributors was prepared on 4/22/05.

FDA

Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system.

Erroneous handling of samples will cause problems after the system is placed in 'Sample-pause'.

The firm faxed the technical bulletin notification to each domestic customer on 10/22/2004. International customers were e-mailed and faxed on the same day.

FDA

Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software.

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

Recall Technical Bulletins were sent out on 6/13/2003 to all Immulite 2000 users instructing them to not install the provided version 2.6 software.