Z-2357-2019 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 28, 2019
- Initiation Date
- July 26, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,784 (USA)
Product Description
Microdot Xtra blood glucose test strips
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.
Distribution Pattern
Illinois
Code Information
LOT NUMBERS 7091101, 7091201, 7091801, 7091902, 7100402, 7100403, 7101002, 7101602, 7101702, 7102403, 7103002, 7110602, 7110703, and 7112702.