Company: Instrumentation Laboratory Co
Date of Enforcement Report: 3/31/04
Class: II
PRODUCT
a) ACL Futura Instrument Analyzer. Recall # Z-0736-04;
b) ACL Advance Instrument Analyzer. Recall # Z-0737-04.
REASON
Software may cause instrument to omit step causing reagent carryover which may effect patient test result.
CODE
a) Software prior to Version V3-5;
b) Software version prior to V2-1.
RECALLING FIRM/MANUFACTURE
Instrumentation Laboratory Co, Lexington, MA, by letter on March 9, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
462 units.
DISTRIBUTION
FL, and Canada.