HSA Alerts Public on Abbott's Voluntary Recall of Medisense Optium™ Blood Glucose Test Strips

The Health Sciences Authority (HSA) is overseeing the voluntary market recall of 43 affected lots of Abbott MediSense Optium™ Blood Glucose Test Strips by Abbott Laboratories (S) Pte Ltd. The blood monitoring device is not affected by this recall.

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      Based on information provided by the company, the probable reason behind the inaccurate readings is related to the test strips taking a longer than expected time to absorb the blood from the patients' finger, which could lead to inaccurate low readings of their blood sugar levels. This may be dependent on the prolonged storage of the strips and their exposure to higher temperatures (exceeding 30°C) for an extended period of time.

4      Abbott Laboratories (S) Pte Ltd has imported into Singapore 43 affected lots. There are three pack sizes of 25, 50 or 100 test strips per box in the affected lots. The 43 affected lot numbers are on the Annex 1 attached. Globally, there may be additional lots that are affected.

5      Abbott Laboratories (S) Pte Ltd has initiated a voluntary recall of the affected lots. This recall is expected to be completed within a week.

Public Advisory

6      HSA advises that:
• Patients who have purchased Abbott MediSense Optium™ Blood Glucose Test Strips in Singapore, to stop using the affected lots (as listed in the attached Annex 1) and seek replacement of unaffected batches
• Patients who have purchased their strips overseas, to check with Abbott Laboratories S Pte Ltd if the test strips are from the affected lots
• Patients who have used these affected test strips should consult a doctor if they have experienced symptoms of high or low blood sugar due to treatment after readings obtained from the affected strips
• Patients may contact their health care provider to determine other testing options especially if they need to adjust their insulin therapy.

7      For return of the affected test strips and other additional information, patients are advised to contact Abbott Laboratories (S) Pte Ltd at 1800 272 2881, or email to ADC-CS.SG@abbott.com.

8      HSA will continue to monitor the situation closely and will take all appropriate actions to protect public health and safety.

HEALTH SCIENCES AUTHORITY
SINGAPORE
24 DECEMBER 2010

Download pdf version here468 KB Published: 24 Dec 2010

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