Device recall

Z-1545-2026: Owner's Booklets and Instructions for Use that are used with the following blood…

FDA device recall · Class I · Trividia Health, Inc.

Key facts

Recall number (Z-number) Z-1545-2026
Recall event 98317
Product Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX Kit/RE4001-01, Leader TRUE METRIX Kit/RE4002-01, Leader TRUE METRIX Meter Only/RE4002-40, CVS TRUE METRIX Kit/RE4007-01SB, GNP TRUE METRIX Meter…
Product code NBW
Recalling firm Trividia Health, Inc.
Recall class Class I
Status Open, Classified
510(k) numbers K140100
FEI number 1000113657

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)