Z-0195-2013Class II

ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a...

Name: Z-0195-2013 ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a...
Creator: Sendx Medical Inc
Published: 2010-01-06
License: https://open.fda.gov/license/

Sendx Medical, Inc. / initiated 2010-01-06 / Terminated / root cause: software

FDA source

Sendx Medical Inc began a recall of ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood... on 2010-01-06. FDA classified it as Class II and gives the reason as "The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer related to the reporting of the hemoglobin fractional parameters". 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-0195-2013
Classification: Class II
Status: Terminated
Initiated: 2010-01-06
Posted: 2012-11-05
Terminated: 2012-11-05
Recalling firm: Sendx Medical, Inc.
Product: ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and therapists. It is 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 recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer related to the reporting of the hemoglobin fractional parameters.
Root cause tag: software
FDA root cause: Software design
Action: SenDx Medical sent a recall letter to all their foreign customers on January 6, 2010, to informed them of the ABL80 FLEX CO-OX recall via the Radiometer Field Action Notification (FAN) system. The Field Action Notes informed the customers of the problem identified and the action to be taken. Customers were instructed to submit confirmation fax#1 to confirm that the customer letter has been distributed to all ABL80 CO-OX customers by January 31, 2010. Customers were instructed to submit confirmation fax #2 to confirm that all ABL80 CO-OX analyzers have been upgraded to version 1.35 by 6/30/10. In the U.S., the customer was provided with a software upgrade CD along with a letter advising them to the issues associated with the recall. Customers with questions were instructed to contact TechLine at (800) 736-0600 opt 2.
Quantity in commerce: 767 units
Distribution: Worldwide Distribution-- US Distribution including the state of Ohio and the countries of Switzerland, Germany, France, Poland, Austria, Italy, Japan, Australia, Denmark, China, Sweden, Norway, Spain, United Kingdom, Netherlands, and Czech Republic.
Product codes and lots: Serial Numbers: all ABL80 FLEX CO-OX analyzers with sofware versions 1.30, 1.31, 1.32, 1.33, and 1.34.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0195-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0195-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-05

Product code CHL

K080370Class IIAbl 80 Co-Ox SystemSendx Medical, Inc. / cleared 2008-07-31

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)