HSA Alerts Public on Bayer's Voluntary Recall of Bayer Contour™ TS 2x25-Count, 25-Count & 10-Count Test Strip Vials
The Health Sciences Authority (HSA) is overseeing the voluntary market recall of Bayer ContourTM TS 2x25-count, 25-count & 10-count test strip vials by Bayer (South East Asia) Pte Ltd. Please refer to the list of affected product codes and frequently asked questions in Annexes 1 and 2.
2 The affected 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 Contour TS blood monitoring device and Bayer Contour TS 50-count test strip vials (product code 1831) are not affected by this recall.
4 This recall, which is also taking place in other countries, affects the Bayer Contour Test Strips as well. However, only the Bayer Contour TS test strips have been imported and supplied in Singapore by Bayer (South East Asia) Pte Ltd.
5 Based on information provided by the company, the inaccurate readings were related to a packaging issue which, under certain conditions, could cause some test strips packaged in some small-count vials to produce a reading of blood glucose level which is lower than the actual blood glucose level during testing.
6 As all Contour TS 2x25-count, 25-count & 10-count test strip vials are affected by this recall, Bayer (South East Asia) Pte Ltd has made sufficient provision for stocks of 50-count test strip vials to ensure continued, uninterrupted market access to unaffected strips. This recall is expected to be completed within a week.
Public Advisory
7 HSA advises patients to do the following:
- If you have purchased a Bayer Contour TS Glucose Meter, stop using the affected Bayer Contour 2x25-count, 25-count & 10-count test strips as soon as you obtain replacements for those strips with the unaffected Contour TS 50-count test strip vials.
- If you have purchased the strips overseas, check with Bayer (South East Asia) Pte Ltd if the test strips are affected.
- Consult your doctor if you have used these affected test strips and experienced symptoms of high or low blood sugar and feel unwell after treatment upon acting on readings obtained from the affected strips.
- Contact your health care provider to determine other testing options if you are in doubt and especially if you need to adjust your insulin therapy or oral diabetic medications.
8 For return of the affected test strips and other additional information, patients are advised to contact Bayer's appointed distributor, DKSH Singapore Pte Ltd, at Tel: 64157287 (operates Monday to Friday from 8.30am to 5.30pm, excluding public holiday) or Bayer customer care at Tel: 64961974 (operates Monday to Friday from 8.30am-5.30pm and Saturday from 8.30am to 1.00pm, excluding public holiday) or email to customercare.sin@dksh.com
9 HSA will continue to monitor the situation closely and will take all appropriate actions to protect public health and safety.
HEALTH SCIENCES AUTHORITY
24 AUGUST 2011
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Published:
HSA Updates