Z-1314-06

D 744 Chloride membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer

Name: Z-1314-06 D 744 Chloride membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer
Creator: Radiometer America Inc
Published: 2005-02-01
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2005-02-01 / Terminated / root cause: manufacturing process

FDA source

Radiometer America Inc began a recall of D 744 Chloride membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer on 2005-02-01. The reason FDA records is "The CI membrane units generate too low values for status and sensitivity during calibration". 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-1314-06
Status: Terminated
Initiated: 2005-02-01
Posted: 2006-08-01
Terminated: 2011-11-18
Recalling firm: Radiometer America, Inc
Product: D 744 Chloride membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer.
Product code: CGZ Electrode, Ion-Specific, Chloride
Reason for recall: The CI membrane units generate too low values for status and sensitivity during calibration.
Root cause tag: manufacturing process
FDA root cause: Other
Action: The recalling firm sent a letter, dated 2/05, to all of their consignees.The letter instructed the customers to discontinue use of the product and discard any remaining stock which they had on hand. The letter was accompanied by replacement chloride membranes to replace the customer''s portion of the suspect lot.
Quantity in commerce: 85/4 unit boxes
Distribution: Nationwide.
Product codes and lots: Lot Code: R0053.

Product code CGZ

K980130Class IIAbl700 Series Blood Gas , Co-Oximetry, Electrolyte & Metabolite SystemRadiometer America, Inc. / cleared 1998-02-09

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)