Device recall

Z-0634-05: DiaSorin GammaCoat Androstenedione - [125I] RIA Kit Catalog No. CA-1725…

FDA device recall · Class III · Diasorin Inc.

Key facts

Recall number (Z-number) Z-0634-05
Recall event 30937
Product DiaSorin GammaCoat Androstenedione - [125I] RIA Kit Catalog No. CA-1725, DiaSorin Stillwater, Minnesota 55082-0285, U.S.A. Lot # 05144. for the quantitative determination of androstenedione levels in serum.
Product code CIZ
Recalling firm Diasorin Inc.
Recall class Class III
Status Terminated
Termination date Jul 22, 2006
510(k) numbers K854650
FEI number 2182595

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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