Company:Instrumentation Laboratory Co.
Date of Enforcement Report 8/3/11
Class ll:
PRODUCT
Instrumentation Laboratory GEM Premier 3500 Blood Gas Analyzer PN 00026000000. The GEM Premier 3500 blood gas analyzer is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood for pH, pC02, p02, Na+, K+, Ca++, glucose, lactate and hematocrit. These parameters, along with derived parameters, aid in the diagnosis of a patient’s acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance. Recall # Z-2673-2011
REASON
Software upgrade: misuse of the barcode gun by repeatedly clicking can cause the instrument to attach test results to an incorrect patient ID.
RECALLING FIRM/MANUFACTURER
Instrumentation Laboratory Co., Bedford, MA, by letter dated April 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
840 units
DISTRIBUTION
Nationwide and Internationally
