Skip to content

Gem Premier 3000 recallZ-0378-06 · Instrumentation Laboratory Co. · initiated Dec 16, 2005

Terminated All recalls posted in January 2006

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 error may report higher results for glucose and lactate

FDA root cause category: Other

What the company is doing

Instrumentation Laboratory notified customers by letter dated December 2005 on 12/16/2005. Customers were notifed if the error message occurs the lab should diable the glucose and lactate channels or remove cartridge. A software upgrade will be released in early 2006.

Recall details

Recall number
Z-0378-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 16, 2005
Posted by the FDA
Jan 11, 2006
Recalling firm
Instrumentation Laboratory Co.
Quantity
2021 units
Product code
CGA
FDA submissions
K052121
Distribution
Nationwide Foreign: Canada

Product description

GEM PREMIER 3000

Code information (models, lots, serial numbers)

Serial numbers starting with 18412

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

How recalls are matched to devices · Editorial policy · Report an error on this page