Julai 2021 : FSCA 5183 - BioFire® - Pneumonia Panel - Increased Risk of False Negative
FSCA 5183 - BioFire® - Pneumonia Panel - Increased Risk of False Negative
Affected Medical Device : FILMARRAY PNEUMONIA PANEL
MDA Reference Number : MDA/FCA/2021-P102
MDA Registration Number : IVDD8796819-29151
Decription : Potential Adenovirus false negatives are due to a 10-100x reduction in sensitivity specifically foradenovirus species C when using all BioFire® PNplusPanel kits within 6 months of expiration.
Local Establishment Contact Detail :
Ruhil Ashvin
ASEAN QA/RA Manager
bioMerieux Malaysia Sdn Bhd
D-22-02, Menara Suezcap 1, KL Gateway No.2 Kerinchi Lestari, Gerbang Kerinchi Lestari, 59200 Kuala Lumpur, Malaysia
Email : [email protected]
