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Instrumentation Laboratory GEM Premier 3500 Blood Gas… recallZ-2673-2011 · Instrumentation Laboratory Co. · initiated May 11, 2011

Terminated All recalls posted in June 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Instrumentation Laboratory Co. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Software upgrade: misuse of the barcode gun by repeatedly clicking can cause the instrument to attach test results to an incorrect patient ID.

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-2673-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 11, 2011
Posted by the FDA
Jun 27, 2011
Recalling firm
Instrumentation Laboratory Co.
Quantity
840 units
Product code
CHL
FDA submissions
K052121
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 description

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 (models, lots, serial numbers)

Serial Numbers range: 09020100 through 11041157.

Other devices under the same FDA submission

12 devices cleared under K052121 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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