FDAClass IIAugust 28, 2019

Microdot Xtra blood glucose test strips recall

Microdot Xtra blood glucose test strips

Why was Microdot Xtra blood glucose test strips recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Microdot Xtra blood glucose test strips
Recalling firm
Cambridge Sensors Limited
Quantity
17,784 (USA)
Distribution
Illinois
Recall date
August 28, 2019
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls