Microdot Xtra blood glucose test strips
FDA Recall Z-2357-2019 · Posted None
Recalling FirmCambridge Sensors Limited
Recall StatusOpen, Classified
Product CodeNBW
Date Initiated2018-07-26
Product Quantity17,784 (USA)
Reason for Recall
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.
Firm Action
On July 26, 2018, the firm sent an email to it's US distributor that requested a sub-recall.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Illinois
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.