Medical device recalls Moderate risk

Cambridge Sensors Limited recalls Microdot Xtra blood glucose test strips

Recall date
July 26, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2357-2019
FDA classification
Class II
Brand / firm
Cambridge Sensors Limited
Sold / distributed
Illinois

Why it was recalled

The firm reported that a faulty cutting/punching machine did not meet specifications after being fitted with new blades and did not correctly "notch" BG test strips intended for use in the US. The impacted strips did not fit into the inlet port of the BG meter, therefore resulting in a delay in BG testing and results.

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

What was recalled

Microdot Xtra blood glucose test strips

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