Z-0457-2009

ABL7XX Calibration 1 Solution S1720. P/N S1720, 944-024 Intended for in vitro testing of samples of whole...

Name: Z-0457-2009 ABL7XX Calibration 1 Solution S1720. P/N S1720, 944-024 Intended for in vitro testing of samples of whole...
Creator: Radiometer America Inc
Published: 2008-09-05
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2008-09-05 / Terminated / root cause: manufacturing process

FDA source

Radiometer America Inc began a recall of ABL7XX Calibration 1 Solution S1720. P/N S1720, 944-024 Intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium... on 2008-09-05. The reason FDA records is "The firm found that for this particular lot that the barcode, used for entering the characteristics of CAL1 Solution into the analyzer, does not reflect the actual values of the solution. As a consequence, the...". 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-0457-2009
Status: Terminated
Initiated: 2008-09-05
Posted: 2008-12-03
Terminated: 2012-04-25
Recalling firm: Radiometer America, Inc
Product: ABL7XX Calibration 1 Solution S1720. P/N S1720, 944-024 Intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb, FHbF). Also, intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2.
Product code: JFP Electrode, Ion Specific, Calcium
Reason for recall: The firm found that for this particular lot that the barcode, used for entering the characteristics of CAL1 Solution into the analyzer, does not reflect the actual values of the solution. As a consequence, the calibration curves for these parameters and thereby the measured results for patient samples and quality controls will be biased.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On, 9/2/2008 the firm sent out recall notification letters requesting their customers discard any Calibration 1 Solution (CAL1) S1720 (part number 944-024), lot WA-04, complete the attached return form and fax it to 800-736-0601. The firm will send out replacements for all affected product that the firm shows was shipped to their location. Further questions could be directed to Technical Support at 800-736-0600, option 2.
Quantity in commerce: 3,200/200ml bottles
Distribution: Worldwide Distribution --- USA including states of AZ, CA, FL, IA, ID, IL, IN, KY, LA, MD, NC, ND, NE, NY, OH, OK, PA, SD, TX, VA, WA, and WI, and country of Canada.
Product codes and lots: P/N S1720, 944-024; Lot: WA-04

Product code JFP

K002290Class IIAbl-700 Series, Model Abl 7Xx (Various Models)Radiometer Medical A/S / cleared 2000-09-13

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)