The Health Products Regulatory Authority has issued a safety notice for a range of blood glucose test strips amid concerns the kits give diabetics faulty insulin readings.
Roche recently announced an urgent recall for selected lots of Accu-Chek Inform II and AccuChek Aviva test strips due to a risk that strip errors might occur or incorrect results may be generated.
The HPRA said Accu-Chek Inform II test strips were only supplied for professional use in Ireland, but Accu-Chek Aviva test strips have been sold for both self-testing and professional use.
The recall comes after Roche identified some lots that showed an increase in strip errors prior to dosing, which could pose serious health consequences for people with diabetes.
“In a limited number of cases the test strip can produce a biased result i.e. a falsely high or a falsely low value, which might not be detected easily and which could lead to erroneous therapy adaptations,” the safety notice said.
All pharmacy staff should be informed of the recall and any adverse events linked to the devices need to be reported to the manufacturer and the HPRA.
The authority has advised people who have the device to stop using it, contact their pharmacy for a replacement, and report any concerns to Roche.
The affected batches sold in Ireland include: Accu-Chek Aviva test strips (50s) 496915, 496809, 496802, 496807, 497391 and Accu-Chek Aviva test strips (10s) 497344.
In a letter to healthcare professionals, Roche Diabetes Care said it had identified the problem as part of its ongoing quality monitoring processes.
“We have thoroughly investigated this issue to identify the root cause of this potential error and have already started to implement the appropriate corrective measures,” it said.
“Please call your local sales representative if you need any additional advice on the operation of AccuChek blood glucose meters and test strips or have any further questions or concerns.
For more information, visit https://www.accu-chek.co.uk.