FDANovember 2, 2020device
MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - 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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
XXX
What to do
FDA enforcement status: Terminated
Brands named
chromsystems instruments chemicalschromsystemschromsystems instruments
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAeTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-1502026-03-02
- FDAeTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-1522026-03-02
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