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U.S. Department of Health and Human Services

Class 2 Device Recall Instrumentation Laboratory GEM Premier 3500 analyzer

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  Class 2 Device Recall Instrumentation Laboratory GEM Premier 3500 analyzer see related information
Date Initiated by Firm May 11, 2011
Date Posted June 27, 2011
Recall Status1 Terminated 3 on March 15, 2013
Recall Number Z-2673-2011
Recall Event ID 58878
510(K)Number K052121  
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood pH - Product Code CHL
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.
Code Information Serial Numbers range: 09020100 through 11041157.
Recalling Firm/
Manufacturer		 Instrumentation Laboratory Co.
180 Hartwell Road
Bedford MA 01730-2443
For Additional Information Contact Carol Marble
781-861-4467
Manufacturer Reason
for Recall		 Software upgrade: misuse of the barcode gun by repeatedly clicking can cause the instrument to attach test results to an incorrect patient ID.
FDA Determined
Cause 2		 Software design
Action Instrumentation Laboratories sent a "FIELD SAFETY NOTIFICATION" letter dated April 2011 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers. Included with the letter was an upgrade package containing Software V7.2.2 disk along with installation instructions. Also included with the upgrade kit was a Upgrade Tracking Form to be completed and returned via fax at 781-861-4207 or via e-mail at ra-usa@ilww.com. Customers with questions were directed to contact their local representative.
Quantity in Commerce 840 units
Distribution Worldwide Distribution-- USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE , INDONESIA, ISRAEL, ITALY, JAPAN , KOREA, REPUBLIC OF CHINA, MALAYSIA, NETHERLANDS , PHILIPPINES, POLAND, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, THAILAND ,TURKEY, and UNITED KINGDOM.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CHL and Original Applicant = INSTRUMENTATION LABORATORY CO.
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