Device recall

Z-3104-2011: Drug Check, Distributed by Express Diagnostics Intl Inc., 1550 Industrial Drive…

FDA device recall · Class II · Express Diagnostics Int'l., Inc.

Key facts

Recall number (Z-number) Z-3104-2011
Recall event 59567
Product Drug Check, Distributed by Express Diagnostics Intl Inc., 1550 Industrial Drive, Blue Earth, MN 56013. Following Cup and Dip product models involved in the recall: 40900 40901 30500-A 30575 -A 30603-A 30671-A 30800-A 30802-3A 30900-A 30950-A 31102-A 40901C 60410-3A 60500-A 60505-A 60524-A 60526-A…
Product code DIC
Recalling firm Express Diagnostics Int'l., Inc.
Recall class Class II
Status Terminated
Termination date Jul 6, 2012
510(k) numbers K042975, K050186, K053175, K063015
FEI number 3014946040

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

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