Device recall

Z-0580-2011: Henry Schein, Inc. OneStep Pro Urine Analyzer, Catalog Number: OneStep Pro Urine…

FDA device recall · Class II · Teco Diagnostics

Key facts

Recall number (Z-number) Z-0580-2011
Recall event 57157
Product Henry Schein, Inc. OneStep Pro Urine Analyzer, Catalog Number: OneStep Pro Urine Analyzer The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern…
Product code KQO
Recalling firm Teco Diagnostics
Recall class Class II
Status Terminated
Termination date Aug 3, 2012
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)