FDA-Device2019-08-28Class II
Microdot Xtra blood glucose test strips
Cambridge Sensors Limited
Hazard
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.
Sold states
Illinois
Affected count
17,784 (USA)
Manufactured in
Units 9 & 10, Cardinal Park, Huntingdon, N/A, United Kingdom
Products
Microdot Xtra blood glucose test strips
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2357-2019Don't want to check this manually?
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