Table 5

The main characteristics of the reviewed publications on the quality of SMBG supplies

StudySampling methodLocationFindings
LifeScan, 2006
LifeScan, 2006
Blackwell, 2007
Bloomberg News, 2007
US FDA, 200615 43 44 59 120
Manufacturer investigation (sampling technique unspecified), recall/alertUSA, CanadaFalsified glucose strips imported from China sold in the USA and Canada resulting in incorrect reading. Six lots identified.
Castel and Breillat, 200855Recall/alertFranceSorF glucose strips: overestimation of blood glucose level, 4 lots affected.
Cheng, 2009121No samplingUSAGlobal review on falsified medical products used in diabetes treatment.
Platt, 200946Recall/alertUSAExpired and recalled glucose strips were sold by the company that was supposed to recycle them.
LifeScan, 2010122Manufacturer investigation (sampling technique unspecified)EgyptFalsified glucose strips giving highly inaccurate results or failing to give result.
Health Sciences Authority, Singapore, 201042Recall/alertSingaporeSorF glucose strips: underestimation of blood glucose concentrations.
MacDonald, 201056Recall/alertFranceSorF glucose strips: underestimation of blood glucose level, 1 lot affected.
Agence Nationale de la Sécurité du Médicament et des Produits de Santé, 2011(a)53Recall/alertFranceSorF 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)52Recall/alertFranceDegraded glucose strips: due to accidental opening of flasks during transport, possible inaccurate result.
Health Sciences Authority, Singapore, 201149Recall/alertSingaporeSorF glucose strips: can give inaccurate reading.
Loftus, 201147Recall/alertIndia, PakistanFalsified glucose strips manufactured in China were found in India. Falsified strips were also found in 2009.
Mori et al, 201127No samplingN/AA review discussing medical device quality in resource-limited settings.
LifeScan, 2013123Manufacturer investigation (sampling technique unspecified)GreeceFalsified glucose strips: 7 lots found.
NBC News, 201354Recall/alertUSASubstandard glucose strips: chemical contamination of strips distributed to 13 countries.
US FDA, 201357Case reportUSASorF glucose meter and strips: overestimation of blood glucose concentrations
US FDA, 201348 58Recall/alertUSATwenty-one lots of SorF glucose strips were found. When used, the strips showed incorrectly low readings.
LifeScan, 2015124Manufacturer investigation (sampling technique unspecified)BangladeshFalsified glucose strips: 5 lots found.
LifeScan, 2015125Manufacturer investigation (sampling technique unspecified)IndiaFalsified glucose strips: possible falsification within 4 lot numbers.
FDA News, 201645Recall/alertUKImproperly sealed glucose strips found circulating.
Nipro Asia Pte Ltd, 201651Recall/alertSingaporeDegraded glucose strips: may give inaccurate result. Degraded due to opened vials during transport, 6 lots affected.
PTS Diagnostics, 201650Recall/alertSingaporeSorF glucose strips: giving inaccurate reading
LifeScan, unknown60Manufacturer investigation (sampling technique unspecified)Bangladesh, China, Egypt, Greece, India and UAEDescribing falsified LifeScan glucose strips.
LifeScan, unknown61No samplingN/AManufacturer policies to fight poor quality medicines through four processes, namely: distribution, identification, enforcement, prevention.
SafeMedicines, unknown126No samplingUSA, Canada, India, Egypt, PakistanArticles 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.