Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

3PLUS1 Multilevel Plasma Calibrator Set Recalled by Chromsystems Instruments & Chemicals GmbH Due to Products do not meet stability criteria and may...

Date: November 2, 2020
Company: Chromsystems Instruments & Chemicals GmbH
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Chromsystems Instruments & Chemicals GmbH directly.

Affected Products

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.

Quantity: 200 packaging units

Why Was This Recalled?

Products do not meet stability criteria and may impact results.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Chromsystems Instruments & Chemicals GmbH

Chromsystems Instruments & Chemicals GmbH has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report