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. 2019 Sep 24;4(5):e001636. doi: 10.1136/bmjgh-2019-001636

Table 5.

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

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.