OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 021 09 18 000
Date submitted: 9/9/2018
Device Type:Alinity hq Analyzer
Medical Device Identifier:List Number: 0968-01

Serial Numbers: See Attachment A
Reason of Field Safety Corrective Action:Abbott Hematology has identified the following issues with the Alinity hq Analyzer:

(1) Lab temperatures exceeding 220 Celsius (C) may cause false positive or elevated Nucleated Red Blood Cell (NRBC) counts and corresponding falsely decreased White Blood Cell (WBC) counts.

(2) Mean Cell Volume (MCV) may be biased for MCV values above approximately 105 femtoliters (fL) and below approximately 70 fL.
Remedy Action:(1) Necessary NRBC-reIated actions when room temperature is above 220 C:

-Samples that are positive for NRBC must be validated using another method to confirm. WBC (including differential, when reported) must also be validated using an alternative method for NRBC positive samples, if the NRBC count could have a significant impact on WBC. For example, if the NRBC count exceeds 10% of the WBC count or is > 0.2x10_9/L, whichever is greater, WBC validation would likely be necessary. This would depend upon your laboratory practices.

-Where possible, maintain laboratory room temperatures between 150 — 220 C.

- Per the Alinity h-series Operations Manual, ensure that review and validation of affected results is performed before reporting if a data invalidating flag marks a parameter result as suspect. In addition, ensure validation of pathological findings indicated by any morphology flag and of all impacted and associated parameters is performed by using appropriate reference methodology, before affected results are reported.

- This issue will be addressed by software and/or hardware upgrades. Your Abbott representative will contact you to schedule upgrades starting in October 2018.

(2) Necessary MCV-related actions:

-Contact your customer service representative if you have calibrated the MCV parameter. Your representative will perform a service visit to verify the calibration. If you did not calibrate MCV since system installation, then the MCV bias issue should not exist. If your instrument performance indicates that MCV requires calibration, contact your customer service representative to request assistance. The service representative will assist you with MCV calibration until a software solution is made available.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:8949B3F9812FF
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott-IVD.pdf