Company: DPC Cirrus, Inc.,
Date of Enforcement report: 2/7/01
Date of recall: 11/3/00 Class: III
Immulite 2000 Automated Immunoassay Analyzer Software
Versions 1.6 and 1.61. Recall No. Z-183-1.
Software code is incorrect for manual dilutions in the Batch Tests by
Rack, which could cause incorrect calculation of results.
MANUFACTURER: DPC Cirrus, Inc., Randolph, NJ
Manufacturer, by facsimile and telephone on November 3, 2000 and November
6, 2000. Firm-initiated recall ongoing.
Nationwide. There are 8 Government accounts. The product was shipped
internationally to Argentina, Australia, Austria, Brazil, Canada, Chile,
China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Finland,
France, Germany, Greece, India, Israel, Italy, Japan, Malaysia, Mexico,
Netherlands, Norway, Pakistan, Poland, Portugal, Russia, Saudi Arabia,
South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand,
Turkey, UK, Venezuela.