Device recall

Z-1447-06: Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi…

FDA device recall · Class III · Roche Diagnostics Corp.

Key facts

Recall number (Z-number) Z-1447-06
Recall event 35873
Product Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, 911,912, 917, Modular and Cobas c 501clinical chemistry analyzers; Roche Catalog/Part Number 10825441001/ US # 722-4402.
Product code CEM
Recalling firm Roche Diagnostics Corp.
Recall class Class III
Status Terminated
Termination date Nov 1, 2006
510(k) numbers K953239
FEI number 1823260

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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