IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by DPC Cirrus Inc., Flanders, NJ 07836
FDA Recall Z-0994-05 · Posted 2005-07-16
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Recalling FirmDPC Cirrus
Recall StatusTerminated
Product CodeJJE
Date Initiated2005-04-22
Date Terminated2006-06-29
Product QuantityThere are 941 units in the United States and 3014 units in the international market.
Reason for Recall
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.
Firm Action
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.
Root Cause
Other
Distribution Pattern
worldwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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