Events

Rappel de VITROS Chemistry Products TRIG Slides

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Ortho-Clinical Diagnostics.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    74950
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0091-2017
  • Date de mise en oeuvre de l'événement
    2016-08-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148885
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Lipase hydrolysis/glycerol kinase enzyme, triglycerides - Product Code CDT
  • Cause
    Ortho clinical diagnostics confirmed that n-acetylcysteine (nac), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with vitros glu, lac, trig, and uric slides assays.
  • Action
    Ortho-Clinical Diagnostics sent an URGENT PRODUCT CORRECTION Letter (Ref. CL2016-152) dated August 11, 2016 via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to all customers who could order and use affected product to inform them that new interferant were identified for GLU, LAC, TRIG and URIC Slides which may cause biased results. Foreign affiliates were informed by e-mail on August 11, 2016, of the issue and instructed to notify their consignees of the issue. For questions, please contact our Ortho CareTM Technical Solutions Center at 1-800-421-3311. For questions regarding this recall call 908-218-8776.

Device

VITROS Chemistry Products TRIG Slides
  • Modèle / numéro de série
    Current/In-date GENs 16, 17, 19, 20, 22, 23, 24, 25, 27 through 32
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) Puerto Rico and Bermuda), Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, and Venezuela.
  • Description du dispositif
    VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides per sales unit), Unique Device Identifier Nos. 10758750008889 and 10758750004768, Rx ONLY, IVD --- || For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Adresse du fabricant
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Société-mère du fabricant (2017)
    The Carlyle Group LP
  • Source
    USFDA