Company: Diasorin Inc
Date of Enforcement Report: 8/28/02
Medusa software, DiaSorin Part 15794, for an OMNI (automated microtiter plate) Instrument used for the ETI-HA-IGMK Plus Enzyme Immunoasay for the Detection of IgM Antibody to Hepatitis A Virus in Human Serum or Plasma.
Recall # Z-1265-2.
As a result of a software error, the cut-off for the ETI-HA-IGMK Plus kit would be incorrectly calculated, potentially causing false negative results to be reported.
Medusa software, DiaSorin Part 15794.
Diasorin Inc., Stillwater, MN, by telephone on June 11 and 12, 2002.
Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Six laboratories had the defective software.
FL, KS, NY and TX.