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  1. GENERI BIOTECH s.r.o., FSCA_UGT1A1_02_2022, gb PHARM UGT1A1

    An incorrectly determined genotype may affect the confirmation or exclusion of Gilbert syndrome. Based on the genotype ...

    Waarschuwing | 30-12-2022

  2. Datascope Corp. Getinge, 2249723-11.16.2022-001-C, Cardiosave Intra-Aortic Balloon Pumps

    Datascope Corp., a subsidiary of Getinge, is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and ...

    Waarschuwing | 30-12-2022

  3. Covidien llc, FA1286, Dermalon™ Monofilament Nylon sutures Monosof™ Monofilament Nylon sutures Novafil™

    Medtronic heeft vastgesteld dat productiefouten in de verpakking van de genoemde niet-absorbeerbare hechtdraden een gat of rimpel ...

    Waarschuwing | 30-12-2022

  4. EPOCAL Inc., POC 23-004, Epoc Host 2 and Epoc NXS Host

    Siemens Healthcare Diagnostics Inc. has confirmed an issue through complaint investigation. The issue has the potential to affect ...

    Waarschuwing | 30-12-2022

  5. Siemens Healthcare Diagnostics Inc, IMC 23-04, IMMULITE® 2000 Thryoglobulin

    The purpose of this communication is to inform you of an issue with the product indicated in Table 1 above and provide ...

    Waarschuwing | 30-12-2022

  6. GE Medical Systems Information Technologies, Inc., FMI 37206, B125P.B105P.B125M.B105M.B155M Patient Monitor

    GE Healthcare is zich ervan bewust dat als bepaalde B1x5P / B1x5M patiëntmonitoren "mmHg" of "kPa" gebruiken als de eenheid voor ...

    Waarschuwing | 30-12-2022

  7. GENERI BIOTECH s.r.o, FSCA_UGT1A1_01_2022, gb PHARM UGT1A1

    The list of PCR cyclers in the User Manual contains incorrect information about the possibility of using the Rotor-Gene PCR ...

    Waarschuwing | 30-12-2022

  8. Ortho Clinical Diagnostics Inc, CL2022-298, ORTHO VISION and VISION Max Analyzers for BioVue

    The purpose of this notification is to inform you of a potential for false positive results during a probe replacement process ...

    Waarschuwing | 30-12-2022

  9. Biohit Oyj, 144-22, BIOHIT ColonView quick test

    lf the specified kit lot has been used, a minor possibility for a false negative result still exists. In such a case there would ...

    Waarschuwing | 30-12-2022

  10. Aesculap AG, FSCA 266, Nasal snare single-use

    Aesculap AG as a legal manufacturer has voluntarily decided to recall the affected products under point 1.2 as a precaution due ...

    Waarschuwing | 30-12-2022