Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system.
FDA Recall Z-0263-05 · Posted 2004-11-30
Recalling FirmDPC Cirrus
Recall StatusTerminated
Product CodeDHA
Date Initiated2004-10-29
Date Terminated2005-01-18
Product Quantity17 UNITS
Reason for Recall
Erroneous handling of samples will cause problems after the system is placed in 'Sample-pause'.
Firm Action
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.
Root Cause
Other
Distribution Pattern
The firm distributed the IMMULITE 2500 nationwide and internationally. The international customers are located in Portugal, Turkey, Australia, Switzerland, Czech Rep.,Germany, Spain, France, Netherlands, Sweden, Denmark, United Kingdom, and Italy.
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.