Device recall

Z-0736-2016: HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory…

FDA device recall · Class II · Instrumentation Laboratory Co.

Key facts

Recall number (Z-number) Z-0736-2016
Recall event 72972
Product HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
Product code GGP
Recalling firm Instrumentation Laboratory Co.
Recall class Class II
Status Terminated
Termination date Aug 30, 2017
510(k) numbers K981200
FEI number 1217183

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)