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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 134 07 18 000
Date submitted: 7/26/2018
Device Type:ARCHITECT EBV VCA IgM Reagent Kit
Description:In Vitro Diagnostic (IVD)
Medical Device Identifier:List Number (LN): 3P66‐25, 3P66‐35

Lot Number: 85278LI00, 85279LI00
Reason of Field Safety Corrective Action:Abbott has identified the two ARCHITECT EBV VCA IgM Reagent lots listed above may show reduced RLU (Relative Light Units) signal when used in combination with certain lots of ARCHITECT EBV VCA IgM Calibrator (LN 3P66‐01).
Remedy Action:-Do not use the combination of reagent lot 85278LI00 and/or 85279LI00 with calibrator lot(s) 71146LI00, 73014LI00, 79576LI00 or 83327LI00.

-Please review this letter with your Medical Director or Laboratory Management and follow your laboratory protocol regarding the need for reviewing previously reported patient results.

-If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter.

-Complete and return the Customer Reply Form

-Please retain this letter for your laboratory records.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:C91D7F2A0F19E
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf