Complaints and Product Alerts
If you experience any problems related to WHO prequalified products or products eligible for WHO procurement, please complete the “User complaint form for reporting problems and/or adverse events related to diagnostic products” and submit to the following email address: firstname.lastname@example.org
What is a Field Safety Notice
Field safety notice may be issued by WHO in response to a complaint or findings of the WHO prequalification assessment - laboratory evaluation, poor performance the field.
If you have any questions, please do not hesitate to contact the WHO Prequalification of Diagnostics programme at email@example.com
Field Safety Notice
There are currently no active Field Safety Notices.
What is a Notice of Concern
A notice of concern may be issued by WHO after an inspection was performed at a site where observations were made that result in concern regarding compliance of the site with specified standards such as ISO 13485:2003 (Medical devices - Quality management systems).
A notice of concern may also be issued if the requested response to the observations noted in an inspection report, detailing the corrective actions taken or proposed to be taken, is not received by WHO on or before the due date (i.e. 90 days from the date when final inspection report sent).
A notice of concern will remain active on the WHO Prequalification of Diagnostics Programme web site until WHO is satisfied that the corrective actions taken are appropriate and have been effectively implemented.
Notice of Concern
Hangzhou Biotest Biotech Co., Ltd.: 17 Futai Road, Yuhang District, Hangzhou 310021, China
Tulip Group, Inc., Qualpro Diagnostics/Orchid Biomedical Systems: 88/99 Phase II, C, Verna Industrial Estate, Verna, Goa 403722, India; and Zephyr Biomedicals: Plot Nos.M46-47, Phase 111B, Verna Industrial Estate, Goa 403722, India.
User complaint form for reporting problems and/or adverse events related to diagnostic products
Formulaire de plainte pour les utilisateurs signalant des problèmes et/ou des événements indésirables en relation avec des produits de diagnostic