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Terminated

GEM PREMIER 3000

FDA Recall Z-0378-06 · Posted 2006-01-11

Recalling FirmInstrumentation Laboratory Co.
Recall StatusTerminated
Product CodeCGA
Date Initiated2005-12-16
Date Terminated2007-05-21
Product Quantity2021 units

Reason for Recall

Software error may report higher results for glucose and lactate

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide Foreign: Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052121GEM PREMIER 3000Instrumentation Laboratory CO · 2005-10-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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