Reported Dec 16, 2020 · Terminated

MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Product Usage: The kit is intended for amino…

Chromsystems Instruments & Chemicals GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Chromsystems Instruments & Chemicals GmbH · Am Haag 12 · Grafelfing, N/A · N/A

Is this the product you have?

  • MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 -
  • Product UsageThe kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder
Lot codes and dates
    • Order No. 0472
    • Lot No. 2019 (expiration 05/01/2022)
Amount recalled
363 vials

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

XXX

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 20, 2021 · Data as of Sep 19, 5:43 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.