Device recall

Z-0979-2007: STA Neoplastine CI Plus (10), (cat. 0667). 12 x 10 ml. in vitro diagnostic for…

FDA device recall · Class III · Diagnostica Stago, Inc.

Key facts

Recall number (Z-number) Z-0979-2007
Recall event 37834
Product STA Neoplastine CI Plus (10), (cat. 0667). 12 x 10 ml. in vitro diagnostic for the determination of prothrombin time (PT).
Product code GJS
Recalling firm Diagnostica Stago, Inc.
Recall class Class III
Status Terminated
Termination date Nov 30, 2009
510(k) numbers K922040
FEI number 2245451

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

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