Chromsystems Instruments & Chemicals GmbH recalls 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid metabolic…

Recall date

November 2, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0536-2021

FDA classification

Class II

Brand / firm

Chromsystems Instruments & Chemicals GmbH

Sold / distributed

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.

Why it was recalled

Products do not meet stability criteria and may impact results.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - 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.