The World Health Organization (WHO) has issued a notice of concern on the following products manufactured by Standard Diagnostics, Inc.

• SD Bioline HIV Ag/Ab Combo
• SD Biolime HIV-1/2 3.0
• SD Bioline Malaria Ag P.f/Pan
• SD Bioline Malaria Ag P.f

An inspection of manufacturing of the above mentioned products was conducted by the WHO Prequalification of Diagnostics Programme from 28 September to 1 October 2010 at the Hagal-clong Giheung-gu site of Standard Diagnostics. On the 3 November 2010, Standard Diagnostics received the WHO Final Inspection Report for this first inspection that contained a significant number of nonconformities but did not include critical nonconformities.

A re-inspection of the Hagal-dong Giheung-gu site and an inspection of the newly acquired Bora-dong Giheung-gu site took place on 6-9 March 2012. The inspection team found that the manufacturer had not effectively implemented rectification of the requirements according to their action plan from the first inspection. The re-inspection revealed a significant number of major and critical nonconformities. There were 5 critical nonconformities detected:

• Lack of adequate document control.
• Misleading information presented to the WHO inspection team.
• Production processes were not sufficiently under control, not QA driven and not independent of production.
• Lack of precise identification and traceability throughout production processes.
• Lack of adequate quality control over in process and release of test kits.

According to WHO, the effectiveness of the quality management system at Standard Diagnostics, Inc. had deteriorated since the first WHO inspection and requires considerable rectification before confidence in the quality of the products being produced by Standard Diagnostics, Inc. is re-established.

WHO will withhold prequalification of all active applications for products manufactured at the above mentioned sites, and close any other applications received. This will remain in effect until these nonconformities have been satisfactorily addressed and WHO has verified and confirmed the acceptability of the corrective actions. For SD bioline HIV-1/2 3.0, it will not be eligible for procurement by WHO until further notice.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 10 July 2012