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Chromsystems Instruments & Chemicals GmbH recalls MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for amino acid
Recalled December 16, 2020 · FDA recall Z-0537-2021 · Chromsystems Instruments & Chemicals
Hazard
Products do not meet stability criteria and may impact results. · FDA Class II
Units
362 vials
Sold at
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.
Description
Products do not meet stability criteria and may impact results.
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.
Manufacturer(s)
Chromsystems Instruments & Chemicals GmbH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →