Z-2357-2019 Class II Ongoing

Recalled by Cambridge Sensors Limited — Huntingdon, N/A

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.