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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 003 10 18 001
Date submitted: 10/23/2018
Manufacturer:Abbott
Device Type:ARCHITECT HAVAb‐IgG Reagent Kit, ARCHITECT HAVAb‐IgM Reagent Kit, Alinity i HAVAb IgG Reagent Kit
Description:IVD
Medical Device Identifier:6C29-22, 6C29-27, 6C30-22, 6C30-27, 8P26-32

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NCMDR Update Code:
Multiple Lot numbers of the affected devices are provided in the attached FSN.
Reason of Field Safety Corrective Action:Abbott has confirmed that a performance shift for the ARCHITECT HAVAb‐IgM, ARCHITECT HAVAb‐IgG and Alinity i HAVAb IgG reagent lots as listed in table above has the potential to generate falsely elevated control and patient sample results.
Remedy Action:- Immediately discontinue use of, and destroy, any remaining inventory of these seven ARCHITECT HAVAb‐IgM, ARCHITECT HAVAb‐IgG and Alinity i HAVAb IgG reagent lots according to your laboratory procedure.

- In the event you are currently using or have inventory of one of these seven lots, immediately contact Customer Support for replacement material.

- 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 any of these seven lots to other laboratories, please inform them of this Product Recall 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:1D267008B6171, A0EEE9094C2CC
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott (ARCHITECT).pdf