Events

Avis De Sécurité sur SYNCHRON Systems SYNCHRON MULTI CALIBRATOR

Selon ALIMS (Agencija za lekove i medicinska sredstva), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Serbia qui a été fabriqué par Beckman Coulter.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2011-12-15
  • Date de publication de l'événement
    2012-02-20
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    https://www.alims.gov.rs/latin/2012/02/20/povlacenje-medicinskog-sredstva-synchron/
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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