The Health Sciences Authority (HSA) is overseeing the voluntary market recall of TRUEresult Blood Glucose Test Strips by Nipro Asia Pte Ltd due to incorrect low glucose results provided by the test strips. Please refer to Annex 1 in the pdf version for the list of affected item codes and lot numbers.
2 The affected TRUEresult Blood Glucose Test Strips may give inaccurate results to diabetic patients, showing readings that are lower than their actual blood sugar level. This could lead to patients failing to control and manage their actual blood glucose adequately due to the inaccurate reading.
3 The TRUEresult Blood Glucose Meter is not affected by this recall.
4 This global recall affects other lots of TRUEresult Blood Glucose Test Strips sold in other countries as well (refer to Annex 2 in the pdf version). Affected lots that are being recalled overseas may be different from the ones recalled in Singapore. As such, patients should contact Nipro Asia (Tel: +65-6836-0661) if they had obtained their TRUEresult Blood Glucose Monitoring System / Test Strips from overseas. Only the lots listed in Annex 1 (in the pdf version) have been imported and supplied in Singapore by Nipro Asia Pte Ltd and Aeras Medical Ptd Ltd.
5 Based on the investigations by Nipro Diagnostics Inc, the inaccurate readings were related to a packaging issue, whereby some of the test strip vials were not properly closed during packaging. The exposed test strips may potentially produce a blood glucose reading which is lower than the actual level.
6 In Singapore, Nipro Asia Pte Ltd will replace the affected test strips with new unaffected lots. The company has informed that replacement stock will be available from week of 30th May 2016 onwards.
HSA’s Advisory to Consumers and Healthcare Professionals
7 For guidance on how to identify the affected lot number information on the device packaging, consumers and healthcare professionals may refer to the pictorial description provided below.
8 HSA advises that:
i. Patients should stop using the affected TRUEresult Blood Glucose Test Strips. Patients should return the affected test strips to Nipro Asia Pte Ltd, who will provide replacement test strips.
ii. Patients who have purchased their strips overseas, to check with Nipro Asia Pte Ltd if the test strips are affected.
iii. Patients who have used the affected test strips should consult a doctor as soon as possible if they feel unwell or are experiencing symptoms of high or low blood sugar.
iv. Patients should contact their healthcare provider to determine other testing options especially if they need to adjust their insulin therapy or oral diabetic medications.
9 For return of the affected test strips and other additional information, patients are advised to contact Nipro Asia Pte Ltd, at Tel: +65-6836-0661 or +65-6836-2542 (Mon – Fri, 9.00am – 6.00pm), or email to niproasia@nipro.com.sg
10 HSA will continue to monitor the situation closely and will take all appropriate actions to protect public health and safety.
HEALTH SCIENCES AUTHORITY
SINGAPORE
27 MAY 2016
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