Device recall

Z-0724-2026: Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.

FDA device recall · Class II · Cepheid

Key facts

Recall number (Z-number) Z-0724-2026
Recall event 97911
Product Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Product code PEU
Recalling firm Cepheid
Recall class Class II
Status Open, Classified
510(k) numbers K143302
FEI number 3004530258

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)