U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The product can cause the analyzer to report values outside the published performance specifications for ph, pco2, cna+, ck+, cca2+ and ccl-.
조치
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.
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
제품 설명
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.