Z-1324-06

Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Numbers: 945-633, distributed one...

Name: Z-1324-06 Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Numbers: 945-633, distributed one...
Creator: Radiometer America Inc
Published: 2005-09-19
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2005-09-19 / Terminated

FDA source

Radiometer America Inc began a recall of Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Numbers: 945-633, distributed one (1) electrode per box on 2005-09-19. The reason FDA records is "Reference electrodes for the firm's ABL 700/800 Blood Gas Analyzers are oversized and will not fit into the instrument". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1324-06
Status: Terminated
Initiated: 2005-09-19
Posted: 2006-08-03
Terminated: 2012-02-24
Recalling firm: Radiometer America, Inc
Product: Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Numbers: 945-633, distributed one (1) electrode per box.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Reference electrodes for the firm's ABL 700/800 Blood Gas Analyzers are oversized and will not fit into the instrument.
FDA root cause: Other
Action: Following the receipt of three (3) customer complaints, on 9/14/2005, the firm issued an E-Mail notification [Management Cover] to their Service Personnel on 9/19/2005. The Management Cover instructed the service personnel to check the electrodes located at their stock and their customer locations; put all electrodes, which cannot be inserted in their call-back stock; and provide for credit to their customers through normal channels. The Service Personnel in turn, contacted their customers via telephone on or around 9/20/2005 and asked that they check their inventories for the presence of any electrodes which would not fit in the analyzer and return any such electrodes to Radiometer America for replacement
Quantity in commerce: 9
Distribution: Nationwide and Canada.
Product codes and lots: Part # 945-633 - Lot #96-02 and Lot #96-03

Product code CHL

K041874Class IIAbl800 FlexRadiometer Medical Aps / cleared 2004-10-08

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)