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 notices are issued by IVD manufacturers when a field safety corrective action takes place. A field safety corrective action is an action taken by the manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of an IVD that is already placed on the market:
- Return of IVD to supplier (recall);
- IVD modification (including changes made to labelling and IFU);
- IVD exchange (swap-out);
- IVD destruction;
- Retrofit by purchased of IVD according to manufacturer modification\design control (usually related to instruments).
These principles also apply to medical devices such as male circumcision devices.
Field Safety Notice
Beckman Coulter – FSN-33176
Cepheid AB - 17FAR013
Standard Diagnostics Inc - FSN - 17002
bioMérieux FSCA 3630
Beckman Coulter Inc - FSN - 31978 - B (update)
Beckman Coulter Inc – FA-31696
Abbott Molecular Inc FA-AM-AUG2017-225v2
Abbott Molecular Inc - FA-AM-AUG2017-224b
Abbott Molecular Inc - FA-AM-AUG2017-224c
Abbott Molecular Inc - FA-AM-AUG2017-225
Abbott Molecular Inc - FA-AM-DEC2016-216a
Abbott Molecular Inc - FA-AM-DEC2016-216aa
If you have any questions, please do not hesitate to contact the WHO Prequalification of Diagnostics programme at email@example.com
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
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
WHO Information Notices for Users
Current WHO information notices for users
WHO reserves the right to issue WHO Information Notices for Users when a threat to public health is perceived. Typically this is when a manufacturer does not act or does not appropriately to reduce the risk related to use of an IVD through adequate field safety corrective action.
WHO also reserves the right to issue WHO Information Notices for Users to supplement manufacturer-issued field safety notices.
If you have any questions, please do not hesitate to contact WHO at firstname.lastname@example.org