Z-0378-06

Gem Premier 3000

Name: Z-0378-06 Gem Premier 3000
Creator: Instrumentation Laboratory Co.
Published: 2005-12-16
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2005-12-16 / Terminated / root cause: software

FDA source

Instrumentation Laboratory Co. began a recall of GEM PREMIER 3000 on 2005-12-16. The reason FDA records is "Software error may report higher results for glucose and lactate". 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-0378-06
Status: Terminated
Initiated: 2005-12-16
Posted: 2006-01-11
Terminated: 2007-05-21
Recalling firm: Instrumentation Laboratory Co.
Product: Gem Premier 3000
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: Software error may report higher results for glucose and lactate
Root cause tag: software
FDA root cause: Other
Action: 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.
Quantity in commerce: 2021 units
Distribution: Nationwide Foreign: Canada
Product codes and lots: Serial numbers starting with 18412

Product code CGA

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)