Device recall

Z-0511-2012: Urine Reagent Strips (URS) 10 Parameters URS-l0-100W 510(K) number: K970250…

FDA device recall · Class II · Teco Diagnostics

Key facts

Recall number (Z-number) Z-0511-2012
Recall event 60476
Product Urine Reagent Strips (URS) 10 Parameters URS-l0-100W 510(K) number: K970250 Devise Listing number: D072377 Each device consists of 100 strips of Urine Reagent Strips 10 parameters packed with a desiccant pouch inside a gray bottle with Teco Diagnostics Label on the bottle and the bottle placed…
Product code KQO
Recalling firm Teco Diagnostics
Recall class Class II
Status Terminated
Termination date Apr 9, 2013
FEI number 1832216

At a glance

  • None 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)