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DH notified of recall of specific lots of Accu-Chek Performa test strips (with photos)
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     The Department of Health (DH) today (May 3) received notification from local supplier Roche Diagnostics (Hong Kong) Limited (Roche) on its voluntary recall of specific lots of Accu-Chek Performa test strips due to a potential safety concern. Patients using the affected products are urged to stop using them immediately.

     According to the information provided by Roche, the test strips of the affected lots potentially show an increase in strip error message or could not be recognised by the device prior to application of blood sample. In a very limited number of cases, the test strip can produce a biased result, i.e. a falsely too high or too low value, which might lead to inappropriate management of a diabetic patient’s condition. The affected lots are:
 
Product Description Affected lots in Hong Kong
Accu-Chek Performa 50's strip 476295, 476258
Accu-Chek Performa 10's strip included in Accu-Chek Performa Meter Kit with Fastclix Device* 476238, 476568
* Only the 10's strip in the meter kit is affected. The Accu-Chek Meter is not affected.

     "Patients are advised to check the lot number on the top flap of the vial packaging as well as on the label of each test strip vial against the affected lot numbers in the table above," a spokesman of the DH said.

     For those who are using the affected lots, they should discontinue using the products immediately and contact the local supplier to obtain instructions on receiving replacement products. Other Accu-Chek blood glucose test strips that are not part of the recall are not affected and can be used as usual.

     Separately, the manufacturer also advised the healthcare professionals using the affected lots to use other testing supplies and equipment to monitor their patients' glucose levels.

     "So far, the DH has not received any reports of adverse incidents related to the affected lots of test strips in Hong Kong," the spokesman said.

     According to the local supplier, approximately 14 500 affected vials have been distributed to the Hospital Authority, the DH, private hospitals and clinics, nursing homes, the universities, drug stores and individual patients.

     The local supplier will contact the healthcare professionals and distributors concerned to recall the affected products. It has also set up hotlines (2485 7512 / 2485 7517) for customer enquiries during office hours.

     "We will alert affected services under the DH, public and private hospitals as well as relevant medical associations to the recall, and will liaise with the local supplier on the follow-up actions," the spokesman added.

     "Members of the public who have been using the product should consult healthcare professionals if in doubt or feeling unwell," the spokesman said.
 
Ends/Thursday, May 3, 2018
Issued at HKT 21:47
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Photo

The Department of Health (DH) today (May 3) received notification from local supplier Roche Diagnostics (Hong Kong) Limited (Roche) on its voluntary recall of specific lots of Accu-Chek Performa test strips due to a potential safety concern. Picture shows the package of Accu-Chek Performa 50's strip.
The Department of Health (DH) today (May 3) received notification from local supplier Roche Diagnostics (Hong Kong) Limited (Roche) on its voluntary recall of specific lots of Accu-Chek Performa test strips due to a potential safety concern. Picture shows the package of Accu-Chek Performa 50's strip.