Company:Instrumentation Laboratory Co., Lexington, MA,
Date of Enforcement Report:5/9/2007
Class:ll

PRODUCT
GEM Premier 4000 Laboratory Analyzer, Recall # Z-0778-2007

REASON
Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result.

CODE
Serial numbers prior to 07020343 with Software versions prior to V1.1.3

RECALLING FIRM/MANUFACTURER
Instrumentation Laboratory Co., Lexington, MA, by Service Reps and e-mail on March 21 and March 27, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
210 units

DISTRIBUTION
Nationwide and Internationally