Device recall

Z-1189-2008: Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic.

FDA device recall · Class II · Bio-Rad Laboratories

Key facts

Recall number (Z-number) Z-1189-2008
Recall event 46728
Product Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic.
Recalling firm Bio-Rad Laboratories
Recall class Class II
Status Terminated
Termination date Mar 7, 2011
PMA numbers P060031
FEI number 3008272466

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event

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)