04

Aug

2011

Cl ll GEM Premier 3500 Blood Gas Analyzer

0

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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