| Class 2 Device Recall Microdot Xtra blood glucose test strips |  |
Date Initiated by Firm | July 26, 2018 |
Create Date | August 22, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2357-2019 |
Recall Event ID |
82867 |
510(K)Number | K083273 |
Product Classification |
System, test, blood glucose, over the counter - Product Code NBW
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Product | Microdot 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
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For Additional Information Contact | Customer 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.
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FDA Determined Cause 2 | Nonconforming Material/Component |
Action | On July 26, 2018, the firm sent an email to it's US distributor that requested a sub-recall. |
Quantity in Commerce | 17,784 (USA) |
Distribution | Illinois |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = NBW
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