Device recall

Z-0522-2021: MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product…

FDA device recall · Class II · Chromsystems Instruments & Chemicals GmbH

Key facts

Recall number (Z-number) Z-0522-2021
Recall event 86699
Product MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
Product code JJY
Recalling firm Chromsystems Instruments & Chemicals GmbH
Recall class Class II
Status Completed
FEI number 3003951180

At a glance

  • None 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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