Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Arcoma AB, FSN-210301C01, 0180/Intuition

   Urgent Field Safety Notice 0180/Intuition.

   Waarschuwing | 22-03-2021

2. AesculapAG, FSN-FSCA254, Unimax

   Aesculap AG meldt Field Safety over Unimax; CE mark was applied without valid declaration of conformity.

   Waarschuwing | 22-03-2021

3. RECIPE Chemicals + lnstruments GmbH, FSN-REKL-340, ClinCal® Whole Blood Calibrator lmmunosuppressants

   This notice informs about an important safety information regarding the calibration of Immunosuppressants in whole blood.

   Waarschuwing | 20-03-2021

4. ARKRAY Factory, Inc., FSN-Afc-fsca-2021-001, SPOTCHEM CALIBRATOR KIT

   Urgent Field Safety Notice SPOTCHEM CALIBRATOR KIT.

   Waarschuwing | 19-03-2021

5. Radiometer Medical ApS., FSN-FAN 915-415, PICO70

   Field Safety Notice: PICO70 Arterial Blood Sampler.

   Waarschuwing | 18-03-2021

6. bioMerieux SA, FSN-FSCA 5109, VIDAS CMV IGM 30 TESTS

   URGENT FIELD SAFETY NOTICE VIDAS® CMV IgM; Calibration issue leading to potential delayed results.

   Waarschuwing | 18-03-2021

7. Hologic, Inc., FSN-CTB-00855, Panther Fusion Tube Tray

   This notification is to inform you of a voluntary recall for Panther Fusion Tube Trays (PN FAB-15004).

   Waarschuwing | 18-03-2021

8. RanD S.p.A., FSN-IR01-21, Steril Milano

   Deze veiligheidswaarschuwing maakt onderdeel uit van een groter Europees onderzoek naar vervalste certificaten. Doordat de ...

   Waarschuwing | 17-03-2021

9. Ortho Clinical Diagnostics (Ortho), LLC, FSN-CL2021-080, ORTHO VISION and ORTHO VISION Max Analyzers

   The purpose of this notification is to inform you that the Wrong Liquid Level (WLL) check will not occur in specific ...

   Waarschuwing | 17-03-2021

10. Sirona Dental Systems GmbH, FSN-8000507299, INTEGO

    Important Customer Information: Intego/Intego Pro Treatment Centers.

    Waarschuwing | 16-03-2021