Reported Jul 13, 2022 · Terminated

MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II

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?

  • MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
Lot codes and dates
  • Model0193
  • Lot Number2821
  • UDI/DI04250317502865
Amount recalled
1457 units

This recall covers 2 products

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

Where it was sold

Why it was recalled

Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.

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 May 15, 2024 · Data as of Sep 19, 4:54 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.