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 : ruhil.ashvinkumar@biomerieux.com

 

 A copy of FSN.