Z-2304-2012Class II

ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes...

Name: Z-2304-2012 ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes...
Creator: Sendx Medical Inc
Published: 2012-06-06
License: https://open.fda.gov/license/

Sendx Medical, Inc. / initiated 2012-06-06 / Terminated / root cause: software

FDA source

Sendx Medical Inc began a recall of ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with... on 2012-06-06. FDA classified it as Class II and gives the reason as "The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient's clinical condition". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2304-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-06
Posted: 2012-08-30
Terminated: 2012-09-04
Recalling firm: Sendx Medical, Inc.
Product: ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases, electrolytes, glucose and oximetry (ABL80 FLEX CO-OX only) in whole blood. The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) analyzer systems are intended for use by trained technologists, nurses, physicians and therapists. They are intended for use in a laboratory environment, near patient or point-of-care setting.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient's clinical condition.
Root cause tag: software
FDA root cause: Software design
Action: Radiometer sent a Field Safety Notice letter dated June 06, 2012 via email to all affected customers. The letter identified the affected product, problem and actions to be taken. Also included is a Note to Users to be placed at the front of customers existing Operator's Manual. Customers were instructed to provide confirmation to Radiometer that all customers have received the letter and the Note to Users. For questions contact your Radiometer representative.
Quantity in commerce: ABL80 FLEX is 1680, ABL80 CO-OX is 1759
Distribution: Worldwide Distribution - US Nationwide including the state of OH.
Product codes and lots: Model Numbers: 393-839 (with 933-082 software) and 393-841 (with 933-132 software) All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2304-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2304-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-30

Product code CHL

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)