FDAFDA · Food and drugs·Recall number Z-0537-2021
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.
Published December 16, 2020 · Recall initiated: November 2, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Products do not meet stability criteria and may impact results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Chromsystems Instruments & Chemicals GmbH
- Distributor
- 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.
- Lot
- Order No. 0471, Lot No. 2019 (expiration 05/01/2022)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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