DPC Cirrus Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software.
Brand
DPC Cirrus
Lot Codes / Batch Numbers
All units.
Products Sold
All units.
DPC Cirrus is recalling Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b due to Version 2.6 software was released however it will not properly handle adjustment slopes.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Version 2.6 software was released however it will not properly handle adjustment slopes.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026