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U.S. Department of Health and Human Services

Class 2 Device Recall Microdot Xtra blood glucose test strips

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 Class 2 Device Recall Microdot Xtra blood glucose test stripssee related information
Date Initiated by FirmJuly 26, 2018
Create DateAugust 22, 2019
Recall Status1 Open3, Classified
Recall NumberZ-2357-2019
Recall Event ID 82867
510(K)NumberK083273 
Product Classification System, test, blood glucose, over the counter - Product Code NBW
ProductMicrodot Xtra blood glucose test strips
Code Information LOT NUMBERS 7091101, 7091201, 7091801, 7091902, 7100402, 7100403, 7101002, 7101602, 7101702, 7102403, 7103002, 7110602, 7110703, and 7112702.
Recalling Firm/
Manufacturer		 Cambridge Sensors Limited
Units 9 & 10
Cardinal Park
Huntingdon United Kingdom
For Additional Information ContactCustomer Service
877-374-4062
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn July 26, 2018, the firm sent an email to it's US distributor that requested a sub-recall.
Quantity in Commerce17,784 (USA)
DistributionIllinois
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NBW
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