Device recall

Z-1230-2016: QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an…

FDA device recall · Class II · Qiagen Sciences LLC

Key facts

Recall number (Z-number) Z-1230-2016
Recall event 73384
Product QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
Product code NCD
Recalling firm Qiagen Sciences LLC
Recall class Class II
Status Terminated
Termination date Aug 16, 2016
PMA numbers P010033
FEI number 3003572099

At a glance

  • None 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)