RegWardenFDA facility compliance records
Facility

CAMBRIDGE SENSORS LIMITED

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2018: 1 recalls20171201820192020202120222023202420252026
  • Recalls (1)

Devices registered here (3)

  • System, Test, Blood Glucose, Over The Counter
    Product code NBW (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1345
  • Single (Specified) Analyte Controls (Assayed And Unassayed)
    Product code JJX (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1660
  • Glucose Dehydrogenase, Glucose
    Product code LFR (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1345

Recalls & enforcement

  • Class IIOngoing2018-07-26
    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 resultin…

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “CAMBRIDGE SENSORS LIMITED (FEI 3004176168) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004176168-cambridge-sensors-limited/

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