FDA recall Z-2357-2019

Product

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

Illinois

Key facts

Status

Ongoing

Initiation date

2018-07-26

Report date

2019-08-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Huntingdon, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2357-2019