Z-1015-2010

Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837...

Name: Z-1015-2010 Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837...
Creator: Radiometer America Inc
Published: 2009-03-26
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2009-03-26 / Terminated / root cause: labeling and UDI

FDA source

Radiometer America Inc began a recall of Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837 with Creatinine modules (8x7). The device is... on 2009-03-26. The reason FDA records is "Analysis of customer data, (for ABL 8X7 customers) has shown that the reference membranes are out of analytical specifications when replaced as specified in the device labeling. These errors in analytical specifications...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1015-2010
Status: Terminated
Initiated: 2009-03-26
Posted: 2010-03-05
Terminated: 2012-05-09
Recalling firm: Radiometer America, Inc
Product: Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837 with Creatinine modules (8x7). The device is packaged four (4) units per box.
Product code: CGL Electrode, Ion Based, Enzymatic, Creatinine
Reason for recall: Analysis of customer data, (for ABL 8X7 customers) has shown that the reference membranes are out of analytical specifications when replaced as specified in the device labeling. These errors in analytical specifications could lead to inadequate or clinical interventions (therapy) or misleading interpretation of patient status in clinical settings.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The recalling firm contacted their customers and notified them of this recall with a letter on 3/26/2009. The letter informs the customer that Radiometer has determined that the Reference Membrane D711 for use in the ABL8x7 Flex Creatinine Analyzer has a shorter in-use lifetime than the previously recommended 1-month interval listed in the Operators Manual. It states that consequently, the firm has changed the recommended replacement intervals as they correspond to the number of samples per day analyzed by the customer and a revised insert is being supplied to the customer which should be placed in the Operators Manual to reflect this new information. The recall notification is also accompanied by an attached response FAX FORM which the customer is asked to complete and to fax back to Radiometer so as to acknowledge receipt of the recall notification letter and the revised insert. Please direct questions to the company TechLine at 1-8007360600 opt 2.
Quantity in commerce: 50 membranes in U. S. distribution
Distribution: The recalled product was distributed customers located in the following states within the U.S.: CT, FL, GA, IL, MA, MD, MN, MO, NC, NM, OH, PA, VA, WA, WI, and WV. Product was also sold in the following countries: Algeria, Australia, Austria, Bahrain, Brazil, Czech Rep., Denmark, England, Estonia, France, Germany, Greece, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland & Turkey.
Product codes and lots: Part Number: 942-058, Article Number: D711

Product code CGL

K051968Class IIAbl8x7 FlexRadiometer Medical Aps / cleared 2006-10-16

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)