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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 040 02 16 000
Date submitted: 2/14/2016
Manufacturer:Bio-Rad Laboratories Inc
Device Type:VARIANT II TURBO HbA1c Kit - 2.0 analytical cartridge
Description:cartridge problem
Medical Device Identifier:Catalog No. 270-2462
Reason of Field Safety Corrective Action:As the chromatography deteriorates, you will notice the broadening of all peaks; however, the lack of a drop-line between the P3 and P4 peaks is the most obvious indicator.

( Please see attachment for more information )
Remedy Action:Bio-Rad recommends the following troubleshooting:

-Replace the analytical cartridge when multiple sequential injections (approximately 5 samples in a row) exhibit no drop-line between the P3 and P4 peaks along with a progressive loss of resolution. The loss of resolution is indicated by the broadening and rounding of all peaks (Figure 2).

NOTE: Sample degradation can result in similar peak appearance, so ensure your samples are not degraded.

-Run quality controls with each run as specified in the instructions for use to evaluate the chromatography. If deteriorating chromatography is suspected, running controls and analyzing the pattern against the prior control run will confirm cartridge performance.
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD
Report Source:NCMDR
Source Ref. Number:EDB5D60FE836F
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: BioRad.pdf