Events

Field Safety Notices about SYNCHRON Systems SYNCHRON MULTI CALIBRATOR

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Beckman Coulter.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2011-12-15
  • Event Date Posted
    2012-02-20
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2012/02/20/povlacenje-medicinskog-sredstva-synchron/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
  • Extra notes in the data
  • Reason
    Loading the mislabeled multi calibrator lot m002642g may produce an unexpected message "t4 cal data, lot 593933 loaded" on the insrument display. if this occurs, multi calibrator set points are not updated. subsequent calibration reports of multi calibrator chemistries will reflect the lot number and set points of the previously loaded multi calibrator diskette. if the above impact goes unnoticed, an operator may calibrate and report results using bottles of lot m002642 calibrator with the set points of a previously loaded lot. calibration and controls will pass acceptance limits using the incorrect set points. triglycerides (tg) is not significantly impacted, however tg-b (blanked) may produce results that can vary up to 12.9% higher than expected. lact set point is included in the multi calibrator diskette for lot m002642g or higher. if the mislabeled m002642g disk was loaded, the lact set point, calibration factor, and all generated results will be zero or out of instrument range low (oir lo).

Device

SYNCHRON Systems SYNCHRON MULTI CALIBRATOR

Manufacturer

Beckman Coulter