Recall Z-2357-2019 ยท NBW System, Test, Blood Glucose, Over The Counter
Cambridge Sensors Limited
Microdot Xtra blood glucose test strips
| Date | Jul 26, 2018 |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | On July 26, 2018, the firm sent an email to it's US distributor that requested a sub-recall. |
| Quantity | 17,784 (USA) |
| Distribution | Illinois |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083273 | MICRODOT XTRA Cambridge Sensors Limited, Nov 19, 2009 |