Z-1261-06

Dri-Tek BG-OX Cartridge, Model #D7120, Cat. #946-003 Cartridges used in the NPT7 Analyzer, an in vitro...

Name: Z-1261-06 Dri-Tek BG-OX Cartridge, Model #D7120, Cat. #946-003 Cartridges used in the NPT7 Analyzer, an in vitro...
Creator: Radiometer America Inc
Published: 2006-05-01
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2006-05-01 / Terminated

FDA source

Radiometer America Inc began a recall of Dri-Tek BG-OX Cartridge, Model #D7120, Cat. #946-003 Cartridges used in the NPT7 Analyzer, an in vitro diagnostic device on 2006-05-01. The reason FDA records is "Air bubbles may be trapped on or close to the O2 sensor in the pO2 chamber of the cuvettes in cartridges used for blood gas analysis on NPT7 analyzer. This produces too high pO2 readings without a question mark". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1261-06
Status: Terminated
Initiated: 2006-05-01
Posted: 2006-07-27
Terminated: 2012-02-24
Recalling firm: Radiometer America, Inc
Product: Dri-Tek BG-OX Cartridge, Model #D7120, Cat. #946-003 Cartridges used in the NPT7 Analyzer, an in vitro diagnostic device.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Air bubbles may be trapped on or close to the O2 sensor in the pO2 chamber of the cuvettes in cartridges used for blood gas analysis on NPT7 analyzer. This produces too high pO2 readings without a question mark.
FDA root cause: Other
Action: The recalling firm initiated this recall with a letter to send to their customers, via Registered Mail, on 5/1/2006. The letter requests that the customers identify and discard the potentially defective cartridges from Lot #R0299. The letter is accompanied by a recall response page to be completed by the customer and faxed or mailed back to the Radiometer so that the customer can receive an equal number of replacement cartridges free-of-charge.
Quantity in commerce: 185
Distribution: Nationwide.
Product codes and lots: D7120 946-003 Cartridges, Lot #R0299, Expiration Date: 02/2008.

Product code CHL

K982928Class IINpt7 Series Ph/blood Gas and Co-Oximetry SystemRadiometer America, Inc. / cleared 1999-01-06

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)