Device recall

Z-3051-2011: "BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories…

FDA device recall · Class III · Bio-Rad Laboratories

Key facts

Recall number (Z-number) Z-3051-2011
Recall event 56251
Product "BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories, STORE FROZEN" The test kit contains slides and substrate. For use as an indirect fluorescent antibody procedure for the detection and semi-quantitation of human autoantibodies.
Product code DHN
Recalling firm Bio-Rad Laboratories
Recall class Class III
Status Terminated
Termination date Aug 22, 2011
510(k) numbers K813592
FEI number 3008272466

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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