Medical device recalls Moderate risk

Roche Diabetes Care, Inc. recalls Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001

Recall date
July 28, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2352-2021
FDA classification
Class II
Brand / firm
Roche Diabetes Care, Inc.
Sold / distributed
Worldwide distribution - US Nationwide distribution.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001

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