FDANovember 2, 2020device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Products do not meet stability criteria and may impact results.
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.
- CPSCAlliance Chemical Recalls 1-K Kerosene Heater Fluid Containers Due to Risk of Serious Injury or Death from Flash Fire, Burn and Child Poisoning; Violates Mandatory Standards for Portable Fuel Containers2026-04-30
- FDAEnalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.2026-04-23
- FDAeTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-1582026-03-02
- FDAeTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-1502026-03-02
- FDAeTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-1572026-03-02
- FDAeTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-1512026-03-02
- FDAeTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-1562026-03-02
- FDAeTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-1522026-03-02
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