FDA Device recall Z-2357-2019
Microdot Xtra blood glucose test strips
- FDA Device
- Class II
- ongoing
- Published 2019-08-28
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
| Agency | FDA Device |
|---|---|
| Recall number | Z-2357-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-07-26 |
| Published | 2019-08-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cambridge Sensors |
| Distribution | IL |
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_info | LOT 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
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