Bd Logic Blood Glucose Monitor and Paradigm Link Blood Glucose Monitor

• 2 recalls, same reason

  • Terminated Z-0560-06 FDA Unclassified (pre-2012) ·initiated 5 Jan 2006 ·on shared 510(k) K041478
  • Terminated Z-0562-06 FDA Unclassified (pre-2012) ·initiated 5 Jan 2006 ·on shared 510(k) K041478

  BD Blood Glucose Monitors may inadvertently switch the Unit of Measure from mg/dL to mmol/L or vice versa during battery insertion or when a meter is dropped.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K041478 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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