Device recall

Z-0376-2007: Bio-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10…

FDA device recall · Class II · Bio-Rad Laboratories Inc

Key facts

Recall number (Z-number) Z-0376-2007
Recall event 37097
Product Bio-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10 Dual Program diagnostic test. This is a specific part of the kit, and only the calibrator diluent is defective. It comes in two kits.
Product code JIT
Recalling firm Bio-Rad Laboratories Inc
Recall class Class II
Status Terminated
Termination date Nov 28, 2007
510(k) numbers K041444
FEI number 2915274

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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