RecallRadar

FDA Device recall Z-2357-2019

Microdot Xtra blood glucose test strips

On 2019-08-28 the FDA classified a Class II recall of Microdot Xtra blood glucose test strips by Cambridge Sensors, citing 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 u….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2357-2019
ClassificationClass II
Statusongoing
Initiated2018-07-26
Published2019-08-28
Last updated2026-09-13 11:55 UTC
CompanyCambridge Sensors
DistributionIL

Product

Microdot Xtra blood glucose test strips

Reason

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.

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2357-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.