Device recall

Z-0992-04: ABX Diagnostics Minotrol 16 Hematology Controls, Normal and High, in vials…

FDA device recall · Class III · R & D Systems,Inc

Key facts

Recall number (Z-number) Z-0992-04
Recall event 29044
Product ABX Diagnostics Minotrol 16 Hematology Controls, Normal and High, in vials distributed by ABX Diagnostics, Irvine, CA; and Horiba LC-TROL 16 (Hematology Reference Controls), Normal and High, in vials distributed by Horiba Ltd., Kyoto, Japan
Product code JPK
Recalling firm R & D Systems,Inc
Recall class Class III
Status Terminated
Termination date Jun 24, 2004
510(k) numbers K843962
FEI number 2182501

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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