Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2357-2019 — Microdot Xtra blood glucose test strips

U.S. FDA — Device Enforcement · United Kingdom · 2018-07-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2357-2019
Date of alert
2018-07-26
Country / jurisdiction
United Kingdom
Risk level
Class II
Risk type
recall
Brand
Cambridge Sensors Limited
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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