WHO Information Notice for users of malaria IVDs 2020/1

Product name: All malaria and G6PD rapid diagnostic tests manufactured by Access Bio Inc. (Annex 1)

WHO-identifier: 2020/1, version 6

Type of action: Advice to national malaria control programme managers and procurement agencies

Date: 14 February 2020

Attention: National malaria control programme managers and their implementing partners, procurement agencies, national regulatory authorities for in vitro diagnostics (IVDs) and national clinical reference laboratories.

Purpose: To alert procurers of malaria and G6PD rapid diagnostic tests (RDTs) and users in the field to concerns for products manufactured by Access Bio Inc., 65 Clyde Rd. Suite A, Somerset, New Jersey 08873, USA.

Description of the problem:

WHO Prequalification of In Vitro Diagnostics Programme has conducted a series of on-site inspections of the quality management system at Access Bio Inc. 65 Clyde Road, Suite A, Somerset NJ, 08873, United States of America in June 2018 and November 2019. 

Critical nonconformities were identified that may impact patient safety, therefore WHO issued a Notice of Concern.   

Advice on action to be taken by the user:

1. Continue to use products manufactured by Access Bio Inc. that have been deployed, on order or in stores.
2. If product problem or adverse event is detected (see definitions in table below):

        -    Send a complaint notification to the manufacturer (contact details in instructions for use).

        -    Copy the complaint notification to WHO via email (rapidalert@who.int) using the WHO IVD complaint form available here

Advice on action to be taken by procurers and their implementing partners:

1. Do not recall products already in the field at health facilities.
2. Do not cancel orders in process. Access Bio Inc will be requested to send samples for lot testing, pre-shipment.
3. If there are suitable alternatives, do not place any new orders for Access Bio Inc malaria and G6PD RDTs, until the non-conformances are resolved and found acceptable by WHO.
4. If there are no suitable alternatives, new orders can be placed for Access Bio Inc malaria and G6PD RDTs. For these new orders, Access Bio Inc will be requested to send samples of lot testing, pre-shipment.

Transmission of this WHO Information Notice for Users:

This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected product has been deployed and used. 

Annex 1. Product names and product codes for products implicated