Device recall

Z-0860-2023: ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788

FDA device recall · Class II · Biomerieux Inc

Key facts

Recall number (Z-number) Z-0860-2023
Recall event 91148
Product ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788
Product code JWY
Recalling firm Biomerieux Inc
Recall class Class II
Status Open, Classified
510(k) numbers K980348
FEI number 1950204

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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)