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Recall Observatory FDA recall evidence

Device product

6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

Z-0521-2021

October 29, 2020

Class II

Product summary

Firm
Chromsystems Instruments & Chemicals GmbH
Event
Event 86699
Status
Completed
Classification
Class II
Quantity
148 package units
Official record key
device-enforcement:Z-0521-2021

Official wording

Reason: Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.

Code information: Order No. 73039, Lot 3219 (expiration 08/01/2021) and Lot 1020 (Expiration 03/01/2022)

Distribution pattern: US Nationwide distribution in the states of NC and NY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.