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Recall Observatory FDA recall evidence

Device product

Microdot Xtra blood glucose test strips

Z-2357-2019

July 26, 2018

Class II

Product summary

Firm
Cambridge Sensors Limited
Event
Event 82867
Status
Ongoing
Classification
Class II
Quantity
17,784 (USA)
Official record key
device-enforcement:Z-2357-2019

Official wording

Reason: 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.

Code information: LOT NUMBERS 7091101, 7091201, 7091801, 7091902, 7100402, 7100403, 7101002, 7101602, 7101702, 7102403, 7103002, 7110602, 7110703, and 7112702.

Distribution pattern: Illinois

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.