FDA Medical Device Recalls (openFDA)
Cambridge Sensors Limited: Microdot Xtra blood glucose test strips
- Recall number
- Z-2357-2019
- Recalling firm
- Cambridge Sensors Limited
- Product
- Microdot Xtra blood glucose test strips
- Status
- Open, Classified
- Initiated
- 2018-07-26
- Posted
- not on file
- Terminated
- not on file
- 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
- Lot, serial or model codes
- LOT NUMBERS 7091101, 7091201, 7091801, 7091902, 7100402, 7100403, 7101002, 7101602, 7101702, 7102403, 7103002, 7110602, 7110703, and 7112702.
- 510(k) numbers
- ["K083273"]
- PMA numbers
- not on file
- Product code
- NBW
- Firm FEI
- 3004176168
- Firm city
- Huntingdon
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28