Z-2357-2019Class II

Microdot Xtra blood glucose test strips

Name: Z-2357-2019 Microdot Xtra blood glucose test strips
Creator: Cambridge Sensors Limited
Published: 2018-07-26
License: https://open.fda.gov/license/

Cambridge Sensors Limited / initiated 2018-07-26 / Open, Classified / root cause: manufacturing process

FDA source

Cambridge Sensors Limited began a recall of Microdot Xtra blood glucose test strips on 2018-07-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2357-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-07-26
Posted: 2019-08-22
Recalling firm: Cambridge Sensors Limited
Product: Microdot Xtra blood glucose test strips
Product code: NBW System, Test, Blood Glucose, Over The Counter
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 17,784 (USA)
Distribution: Illinois
Product codes and lots: LOT NUMBERS 7091101, 7091201, 7091801, 7091902, 7100402, 7100403, 7101002, 7101602, 7101702, 7102403, 7103002, 7110602, 7110703, and 7112702.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2357-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2357-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-08-28	2019-08-22

Product code NBW

K083273Class IIMicrodot XtraCambridge Sensors Limited / cleared 2009-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)