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A Resized Recall Image cb1May 22 2018

A recall has been issued for selected batches of blood glucose test strips used with Roche Diabetes Care’s Accu-Chek devices. 

The following batches of test strips are included in the recall:

Accu-Chek Aviva – 50s

  • 497392
  • 497391
  • 496915
  • 496809
  • 496802
  • 496807

Accu-Chek Aviva – 10s 

  • 497344
  • 497392

Accu-Chek Performa – 10s

  • 476597
  • 476646

Accu-Chek Performa 10s test strips included within the Accu-Chek Performa Nano mmol Kit:

  • 10153116
  • 10153114
  • 10153115
  • 10153112
  • 10153111

Accu-Chek Inform II test strips: 

  • 476614
  • 476617
  • 476618
  • 476340,
  • 476605
  • 476638
  • 476639
  • 476653

Concerns have been raised that affected test strips “may give increased strip error messages prior to dosing with blood and in some cases may give false high or low readings, which may be hard to detect,” said the MHRA.

It is asking healthcare professionals to identify patients who use Accu-Chek Aviva, Accu-Chek Aviva Nano, Accu-Chek Aviva Expert, Accu-Chek Aviva Combo, Accu-Chek Aviva Insight, Accu-Chek Performa Nano meters, and advise them not to use affected test strips.

In addition, the MHRA said it understands that Accu-Chek Inform II test strips have only been supplied by Roche for professional use in the UK, so all relevant members of staff should be alerted.

A field safety notice (FSN) has been issued with full details of the affected products. Further information is available from Roche Diabetes Care on 01444 106000 or via This email address is being protected from spambots. You need JavaScript enabled to view it..

Links:
MHRA announcement 
MHRA Field Safety Notice         

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