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Recall Observatory FDA recall evidence

Device product

MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.

Z-0537-2021

November 02, 2020

Class II

Product summary

Firm
Chromsystems Instruments & Chemicals GmbH
Event
Event 86719
Status
Terminated
Classification
Class II
Quantity
362 vials
Official record key
device-enforcement:Z-0537-2021

Official wording

Reason: Products do not meet stability criteria and may impact results.

Code information: Order No. 0471, Lot No. 2019 (expiration 05/01/2022)

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of CA and NY; The countries of Australia, Belgium, Brazil, Germany, Finland, France, Greece, Israel, Italy, Canada, Croatia, Kuwait, Austria, Russia, Switzerland, South Africa, Taiwan, Turkey, and United Arab Emirates.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Products do not meet stability criteria and may impact results.