Device recall

Z-1033-2017: PREMIER EHEC and PREMIER EHEC Bulk.

FDA device recall · Class II · Meridian Bioscience Inc

Key facts

Recall number (Z-number) Z-1033-2017
Recall event 75651
Product PREMIER EHEC and PREMIER EHEC Bulk.
Product code GNA
Recalling firm Meridian Bioscience Inc
Recall class Class II
Status Terminated
Termination date Aug 16, 2017
510(k) numbers K953362
FEI number 1524213

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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)