Z-0846-03

GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. Part No. 24345004 (450 Sample Size) For...

Name: Z-0846-03 GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. Part No. 24345004 (450 Sample Size) For...
Creator: Instrumentation Laboratory Co.
Published: 2003-03-07
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2003-03-07 / Terminated / root cause: labeling and UDI

FDA source

Instrumentation Laboratory Co. began a recall of GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. Part No. 24345004 (450 Sample Size) For In-Vitro Diagnostic Use on 2003-03-07. The reason FDA records is "Incorrect bar code applied to cartridges could result in inaccurate pO2 value". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0846-03
Status: Terminated
Initiated: 2003-03-07
Posted: 2003-05-20
Terminated: 2012-05-23
Recalling firm: Instrumentation Laboratory Co.
Product: GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. Part No. 24345004 (450 Sample Size) For In-Vitro Diagnostic Use
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Incorrect bar code applied to cartridges could result in inaccurate pO2 value
Root cause tag: labeling and UDI
FDA root cause: Other
Action: IL notifed customers by telephone on 3/7/03, requesting the return or discard of the cartridges.
Quantity in commerce: 2
Distribution: CA, FL, NY, PA, TN,
Product codes and lots: Lot Number: 306360 Expires: 8/31/2003

Product code CHL

K992834Class IIGem Premier 3000Instrumentation Laboratory CO / cleared 1999-11-24

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)