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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 118 06 18 000
Date submitted: 6/28/2018
Manufacturer:Abbott
Device Type:Alinity hq Analyzer
Description:Analyzers, Laboratory, Hematology
Medical Device Identifier:List Number: 09P68‐01
Reason of Field Safety Corrective Action:Abbott Hematology has identified a potential issue with the Alinity hq Analyzer. Reagent bottles are pierced by a needle assembly connected to an air line (tubing) that serves to vent reagents so that reagents will feed into their respective reagent supply lines. It was determined that liquid from a reagent bottle could leak through the check valve of the air line, which is connected to a common air tubing that is shared by other reagent air lines. This can result in cross‐contamination of reagents and will impact the ability to process samples.
Remedy Action:• Your Abbott representative will be contacting you to replace the vent system starting in July 2018.
• Until the improved vent system is installed on your Analyzer, continue to confirm that quality control results are within the acceptable limits before patient samples are run. If you experience the described issue, contact customer service for support.
• Ensure that you have a back‐up instrument or an alternative method of generating hematology patient results should the instrument become inoperable.
• If you have forwarded the product listed above to other laboratories, please inform them of this product information and provide to them a copy of this letter.
• Please return the Reply Form and retain this letter for your laboratory records.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:84A64612CF251
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf