Table 3.

Examples of quality issues related to medical devices and in vitro diagnostics

Test type	Area	Quality	Date/reference
Microkeratomes	Asia	Manufacturer specifications	200131
Blood glucose meter	Africa	Sensitivity - tropics	200332
Boehringer Mannheim-lactate test strips	Asia	Tampered expiry date	200433
Antibiotic discs	Asia	Inconsistent results	200634
Antiseptic	South America	Substandard efficacy	200635
Antibiotic discs	South America	Inconsistent results	200736
Fuchsin dye	Africa/Asia	Impurity in powders	200937

Note: Data from Mori et al.³⁰

These data are however limited by the fact that there are very few reports in the scientific literature, with much of the information from the gray literature, especially in relation to HIV/AIDS and Dengue test kits. In addition, the poor practices in terms of poor laboratory practices and lack of training, including the ability to interpret results will also play a role in concealing inaccurate diagnoses due to poor quality IVDs.³⁸