Events

Recall of Device Recall SenDx Medical Inc. ABL80FLEX

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sendx Medical Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61178
  • Event Risk Class
    Class 2
  • Event Number
    Z-1384-2012
  • Event Initiated Date
    2012-01-30
  • Event Date Posted
    2012-04-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107472
  • Notes / Alerts
    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.
  • Extra notes in the data
    Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
  • Reason
    The product can cause the analyzer to report values outside the published performance specifications for ph, pco2, cna+, ck+, cca2+ and ccl-.
  • 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.

Device

Device Recall SenDx Medical Inc. ABL80FLEX
  • Model / Serial
    Model number: 393-839 Serial number(s): 304157, 304160 and 304162 to 305414 for ABL80 FLEX analyzers
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    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.
  • Manufacturer
    Sendx Medical Inc

Manufacturer

Sendx Medical Inc
  • Manufacturer Address
    Sendx Medical Inc, 1945 Palomar Oaks Way, Carlsbad CA 92011-1300
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA