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Terminated

GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reagent Cartridge. Part No. 24330004 (300 Sample Size) For In-Vitro Diagnostic Use

FDA Recall Z-0845-03 · Posted 2003-05-20

Recalling FirmInstrumentation Laboratory Co.
Recall StatusTerminated
Product CodeCHL
Date Initiated2003-03-07
Date Terminated2012-05-23
Product Quantity16

Reason for Recall

Incorrect bar code applied to cartridges could result in inaccurate pO2 value

Firm Action

IL notifed customers by telephone on 3/7/03, requesting the return or discard of the cartridges.

Root Cause

Other

Distribution Pattern

CA, FL, NY, PA, TN,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992834GEM PREMIER 3000Instrumentation Laboratory CO · 1999-11-24

Official Source

View FDA Recall →

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

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