More details on Roche test strip recall

By Editor
15th May 2018
Medical devices

Roche say selected lots of  its Accu-Chek® Aviva and Accu-Chek Performa test strips are potentially showing an increased number of strip errors prior to dosing or biased results.

The company is carrying out a wholesale recall of certain batches of the products after problems were picked up during the manufacturing process, as revealed by the DT last week.

A letter issued through the MHRA said: “At Roche Diabetes Care we hold our products to the highest standards of quality and are committed to communicating any issues impacting the operation of our products. This is why we would like to inform you today about an issue that might occur in certain lots of the Accu-Chek Aviva , Accu-Chek Performa test strips, and Accu-Chek Performa strips that have been included in Accu-Chek Performa Nano meter kits.

“As part of our ongoing quality monitoring and market surveillance processes, we have identified certain test strip lots that potentially show an increase in strip errors prior to dosing. Due to the designed fail-safe in the blood glucose meter, the issue can be identified by an error message displayed on the meter upon strip insertion or through the device not recognising the test strip. However, 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 you might not be able to detect easily and which could lead to incorrect therapy adaptations.”

The affected UK products are:

  • Accu-Chek Aviva 50s
  • Accu-Chek Aviva 10s (sold in retail only)
  • Accu-Chek Performa 10s (sold in retail only)
  • Accu-Chek Performa 10s contained with Accu-Chek Performa Nano meter kits

The company is urging people with diabetes to check the lot numbers of their test strip supplies against the complete list of lot numbers listed below. People can also do this online by visiting www.accu-chek.co.uk/customer-service/field- safety-notices. They can find the lot number on the top flap of the vial carton packaging as well as on the label of each test strip vial as shown in the picture below.

LOT NUMBERS UK

ACCU-CHEK AVIVA STRIPS (50s)

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

ACCU-CHEK AVIVA STRIPS (10s)

  • 497344
  • 497392

ACCU-CHEK PERFORMA STRIPS (10s)

  • 476597
  • 476646

Accu-Chek Performa Nano mmol Kit (please note that the FSN only applies to the pack of Performa 10 test strips contained within the kit)

  • 10153116
  • 10153114
  • 10153115
  • 10153112
  • 10153111

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