Z-1406-06

D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers

Name: Z-1406-06 D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers
Creator: Radiometer America Inc
Published: 2005-01-12
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2005-01-12 / Terminated / root cause: manufacturing process

FDA source

Radiometer America Inc began a recall of D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers on 2005-01-12. The reason FDA records is "QC Bias-a solution used in the manufacturing of the membrane had a different composition which introduces a bias of 20 mpH". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1406-06
Status: Terminated
Initiated: 2005-01-12
Posted: 2006-08-26
Terminated: 2011-09-14
Recalling firm: Radiometer America, Inc
Product: D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: QC Bias-a solution used in the manufacturing of the membrane had a different composition which introduces a bias of 20 mpH.
Root cause tag: manufacturing process
FDA root cause: Other
Action: The firm contacted their customers and informed them of this problem and provided a workaround procedure, in a a letter dated 1/12/2005. A ''Field Action Notification'' (FAN) was issued to the firm''s Field Service personnel on 1/21/2005. The letter instructs their personnel to update the NPT7 application software on all units to V3.05 and to hand over a copy of the letter ''Changes related to the Qualicheck2+ and NPT7,'' to the user/customers. In addition, the firm''s personnel were instructed to remove any of the suspect cartridges found on-hand at each customer location; destroy them;and replace them with different lot numberd product.
Quantity in commerce: 545
Distribution: The recalled device component was distributed to a total of 56 customers, nationwide located in the following states: AL, AR, AZ, CA, CO, GA, ID, IL, KA, MA, ME, MI, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT & WA.
Product codes and lots: Lot R0187, Expiration Date: Sept. 2005; and Lot R0016, Expiration Date: 08/2005.

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)