Device recall

Z-1212-2014: FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed…

FDA device recall · Class I · Abbott Diabetes Care, Inc.

Key facts

Recall number (Z-number) Z-1212-2014
Recall event 67472
Product FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, Alameda, CA The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Meter can…
Product code NBW
Recalling firm Abbott Diabetes Care, Inc.
Recall class Class I
Status Terminated
Termination date Aug 11, 2015
510(k) numbers K092638
FEI number 3002803444

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)