Jun 2021 : Field Safety Notification on Access CEA (FA-000602) : Duplicate lot numbers for current and expired Access CEA reagent packs.
Field Safety Notification on Access CEA (FA-000602) : Duplicate lot numbers for current and expired Access CEA reagent packs.
Affected Medical Device : Access CEA Reagent
MDA Reference Number : MDA/FCA/2021-P079
MDA Registration Number : IVDC53646161518
Decription : CEA reagent pack lot number 195018 scanned with an expiration date of 15Jan2012 and showed as expired. The expiration date scanned in the system did not align with the expiration date of 5Jan2022 printed on the reagent pack.
Local Establishment Contact Detail :
Winnie Hii Lin Lin
REGULATORY SPECIALIST
No. 18, Jalan Tandang 51/205A, Seksyen 51 46050 Petaling Jaya Selangor Darul Ehsan Malaysia
Office: 603 7772 8256
www.beckmancoulter.com
Email : [email protected]
