Table 5.
Study | Sampling method | Location | Findings |
LifeScan, 2006 LifeScan, 2006 Blackwell, 2007 Bloomberg News, 2007 US FDA, 200615 43 44 59 120 |
Manufacturer investigation (sampling technique unspecified), recall/alert | USA, Canada | Falsified glucose strips imported from China sold in the USA and Canada resulting in incorrect reading. Six lots identified. |
Castel and Breillat, 200855 | Recall/alert | France | SorF glucose strips: overestimation of blood glucose level, 4 lots affected. |
Cheng, 2009121 | No sampling | USA | Global review on falsified medical products used in diabetes treatment. |
Platt, 200946 | Recall/alert | USA | Expired and recalled glucose strips were sold by the company that was supposed to recycle them. |
LifeScan, 2010122 | Manufacturer investigation (sampling technique unspecified) | Egypt | Falsified glucose strips giving highly inaccurate results or failing to give result. |
Health Sciences Authority, Singapore, 201042 | Recall/alert | Singapore | SorF glucose strips: underestimation of blood glucose concentrations. |
MacDonald, 201056 | Recall/alert | France | SorF glucose strips: underestimation of blood glucose level, 1 lot affected. |
Agence Nationale de la Sécurité du Médicament et des Produits de Santé, 2011(a)53 | Recall/alert | France | SorF glucose strips: resulting in overestimation of blood glucose level, 1 lot affected. |
Agence Nationale de la Sécurité du Médicament et des Produits de Santé, 2011(b)52 | Recall/alert | France | Degraded glucose strips: due to accidental opening of flasks during transport, possible inaccurate result. |
Health Sciences Authority, Singapore, 201149 | Recall/alert | Singapore | SorF glucose strips: can give inaccurate reading. |
Loftus, 201147 | Recall/alert | India, Pakistan | Falsified glucose strips manufactured in China were found in India. Falsified strips were also found in 2009. |
Mori et al, 201127 | No sampling | N/A | A review discussing medical device quality in resource-limited settings. |
LifeScan, 2013123 | Manufacturer investigation (sampling technique unspecified) | Greece | Falsified glucose strips: 7 lots found. |
NBC News, 201354 | Recall/alert | USA | Substandard glucose strips: chemical contamination of strips distributed to 13 countries. |
US FDA, 201357 | Case report | USA | SorF glucose meter and strips: overestimation of blood glucose concentrations |
US FDA, 201348 58 | Recall/alert | USA | Twenty-one lots of SorF glucose strips were found. When used, the strips showed incorrectly low readings. |
LifeScan, 2015124 | Manufacturer investigation (sampling technique unspecified) | Bangladesh | Falsified glucose strips: 5 lots found. |
LifeScan, 2015125 | Manufacturer investigation (sampling technique unspecified) | India | Falsified glucose strips: possible falsification within 4 lot numbers. |
FDA News, 201645 | Recall/alert | UK | Improperly sealed glucose strips found circulating. |
Nipro Asia Pte Ltd, 201651 | Recall/alert | Singapore | Degraded glucose strips: may give inaccurate result. Degraded due to opened vials during transport, 6 lots affected. |
PTS Diagnostics, 201650 | Recall/alert | Singapore | SorF glucose strips: giving inaccurate reading |
LifeScan, unknown60 | Manufacturer investigation (sampling technique unspecified) | Bangladesh, China, Egypt, Greece, India and UAE | Describing falsified LifeScan glucose strips. |
LifeScan, unknown61 | No sampling | N/A | Manufacturer policies to fight poor quality medicines through four processes, namely: distribution, identification, enforcement, prevention. |
SafeMedicines, unknown126 | No sampling | USA, Canada, India, Egypt, Pakistan | Articles discussing falsified medical products used in the treatment of diabetes (including glucose strips) found globally. |
FDA, Food and Drug Administration; N/A, not applicable; SMBG, self-monitoring of blood glucose; SorF, substandard or falsified; UAE, United Arab Emirates.