Company: Diasorin Inc.
Date of Enforcement Report: 11/16/2005
Class:II
PRODUCT
ETI-LAB Applications Disk (for programming Bio-Rad HIV-1/HIV-2 Plus O EIA Assay), Recall # B-0140-6
REASON
Defect in the design of HIV-1/2 testing software resulting in an incorrect incubation temperature.
CODE
Version 1.0
RECALLING FIRM/MANUFACTURER
Diasorin, Inc., Stillwater, MN, by telephone and letter dated May 13, 2004. Firm initiated recall is complete..
VOLUME OF PRODUCT IN COMMERCE
11
DISTRIBUTION
MA, NY, MT, AL, MS, SD, LA, and CT