Recall Z-2357-2019— Cambridge Sensors Limited

Name: FDA recall Z-2357-2019
Creator: U.S. Food and Drug Administration
Published: 2018-07-26

Class II · Ongoing

Class II FDA medical device recall by Cambridge Sensors Limited, initiated 2018-07-26. It names one FDA 510(k) clearance: K083273. 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..

Recalling firm: Cambridge Sensors Limited
Classification: Class II
Status: Ongoing
Initiated: 2018-07-26
Firm location: Huntingdon, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K083273 — MICRODOT XTRACambridge Sensors Limited·cleared 2009-11-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Microdot Xtra blood glucose test strips

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.