Company: Instrumentation Laboratory Co., Lexington, MA.
Date of Enforcement Report:1/25/2006
Class:lI
PRODUCT
GEM PREMIER 3000, Point-of-care blood analyzer. Recall # Z-0378-06
REASON
Software error may report higher results for glucose and lactate.
CODE
Serial numbers starting with 18412
RECALLING FIRM/MANUFACTURER
nstrumentation Laboratory Co., Lexington, MA, by letter dated December 16, 2005. Firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
2021 units
DISTRIBUTION
Nationwide and Canada
