FDAClass IISeptember 1, 2021

Accu-Chek Aviva Plus Test Strip recall

Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001

Why was Accu-Chek Aviva Plus Test Strip recalled?

Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.

Product
Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001
Recalling firm
Roche Diabetes Care, Inc.
Quantity
10,546,420 (US), 19,120,668 (OUS)
Distribution
Worldwide distribution - US Nationwide distribution.
Recall date
September 1, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls