Z-2357-2019 Class II Ongoing
FDA device recall Z-2357-2019 was initiated by Cambridge Sensors Limited on July 26, 2018 and is designated Class II. 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 imp… The recall status is ongoing. Affected quantity: 17,784 (USA).
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.