Z-1384-2012

SenDx Medical Inc ABL80FLEX Blood Gas, pH, Electrolyte, and Metabolite System The ABL80 FLEX is a portable...

Name: Z-1384-2012 SenDx Medical Inc ABL80FLEX Blood Gas, pH, Electrolyte, and Metabolite System The ABL80 FLEX is a portable...
Creator: Sendx Medical Inc
Published: 2012-01-30
License: https://open.fda.gov/license/

Sendx Medical, Inc. / initiated 2012-01-30 / Terminated / root cause: manufacturing process

FDA source

Sendx Medical Inc began a recall of SenDx Medical Inc ABL80FLEX Blood Gas, pH, Electrolyte, and Metabolite System The ABL80 FLEX is a portable, automated analyzer that measures pH, blood gases... on 2012-01-30. The reason FDA records is "The product can cause the analyzer to report values outside the published performance specifications for pH, pCO2, cNa+, cK+, cCa2+ and cCl-". 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-1384-2012
Status: Terminated
Initiated: 2012-01-30
Posted: 2012-04-09
Terminated: 2012-07-13
Recalling firm: Sendx Medical, Inc.
Product: SenDx Medical Inc ABL80FLEX Blood Gas, pH, Electrolyte, and Metabolite System The ABL80 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and hematocrit in whole blood. The ABL80 FLEX 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 product can cause the analyzer to report values outside the published performance specifications for pH, pCO2, cNa+, cK+, cCa2+ and cCl-.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: SenDx Medical sent Customers notification letters dated January 30th, 2012, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customer. We have recently become aware of a possible condition in a limited number of ABLBO FLEX analyzers configured with a specific Control PCe lerinted Circuit Board), which can cause the analyzer to report values outside the published performance specifications for pH, pCOz, cNa*, cK*, cCa2* and cCl-. Customers were instructed to immediately implement Alternative 1 or 2 until the signal data PCB is replaced. Alterative I: Stop the use of all affected analyzers until corrective actions can be performed on these analyzers. Alternative 2: Verify proper function of the affected analyzers immediately following every patient sample measurement by measuring a manual QC sample. Customers were asked to complete the fax form acknowledging receipt of the notice and provided a contact for Technical Support at 1-800-736-0600 opt.4.
Quantity in commerce: 819 analyzers and 44 signal data PCBs
Distribution: One US consignee in state of OH. Other consignees are international such as Australia, France, Netherlands, Denmark, China, United Kingdom, Turkey, Switzerland, Japan, India, Poland, Spain, and Germany. Distribution list submitted with supporting doc.s
Product codes and lots: Model number: 393-839 Serial number(s): 304157, 304160 and 304162 to 305414 for ABL80 FLEX analyzers

Product code CHL

K051804Class IIAbl80 Flex AnalyzerSendx Medical, Inc. / cleared 2005-11-01

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)