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 : LHII@beckman.com

 A copy of FSN.