The Department of Health (DH) today (February 22) draws public's attention to the recall of certain lots of a blood glucose test strip in France. The affected product is MylifeTM Pura® (box of 100’s) manufactured by Bionime Corporation. The test strips may give falsely high blood glucose readings. 

 

DH was informed by the French medical device regulatory authority, Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS) about the recall. According to AFSSAPS, the problem came to their notice when several reports of overestimation of blood glucose levels were received. Further investigation revealed that the problem was due to the accidental opening of the unsealed vials of the test strips during transportation from the distributor in France to the pharmacies. As the test strips are very sensitive towards air exposure, they may lose its performance, giving falsely high readings. The manufacturer has since then, taken preventive action by starting to seal all the vials with a protective film. 

 

A spokesman for DH explains that falsely high blood glucose readings may mislead a diabetic patient into inappropriate management of his/her condition, resulting in hypoglycaemia - indeed, such a case has been reported in France. 

 

So far, DH has not received any local report of adverse events arising from using the product. 

 

Although there is currently no readily available evidence to suggest that the affected product has ever been exported to Hong Kong, DH is following up with the manufacturer to verify if this is indeed the case. Meanwhile, as a precautionary measure, members of the public who may have the above in their hands are advised to stop using any vials which come as  unsealed and surrender them to DH's Medical Device Control Office at Room 3101, 31/F, Hopewell Centre, 183 Queen's Road East, Wan Chai. 

 

"For those customers who have used the said product and are either feeling unwell or in doubt, they should consult their healthcare professionals for advice as soon as possible," the spokesman stresses. 

 

Ends/Wednesday, February 22, 2012