Z-2673-2011

Instrumentation Laboratory GEM Premier 3500 Blood Gas Analyzer PN 00026000000 The GEM Premier 3500 blood gas...

Name: Z-2673-2011 Instrumentation Laboratory GEM Premier 3500 Blood Gas Analyzer PN 00026000000 The GEM Premier 3500 blood gas...
Creator: Instrumentation Laboratory Co.
Published: 2011-05-11
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2011-05-11 / Terminated / root cause: software

FDA source

Instrumentation Laboratory Co. began a recall of 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... on 2011-05-11. The reason FDA records is "Software upgrade: misuse of the barcode gun by repeatedly clicking can cause the instrument to attach test results to an incorrect patient ID". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2673-2011
Status: Terminated
Initiated: 2011-05-11
Posted: 2011-06-27
Terminated: 2013-03-15
Recalling firm: Instrumentation Laboratory Co.
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.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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.
Root cause tag: software
FDA root cause: 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 [email protected]. 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.
Product codes and lots: Serial Numbers range: 09020100 through 11041157.

Product code CHL

K052121Class IIGem Premier 3000Instrumentation Laboratory CO / cleared 2005-10-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)