The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0539-2021·Announced 2020-12-16

Chromsystems Recalls MassChrom Amino Acid Analysis Plasma Control Level III

Chromsystems Instruments & Chemicals GmbH is voluntarily recalling 342 vials of MassChrom Amino Acid Analysis Plasma Control Level III due to a Class II device defect.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation that may cause temporary or medically reversible adverse health consequences. No specific injuries or illnesses are reported in the source text, placing it in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Chromsystems Instruments & Chemicals GmbH is voluntarily recalling 342 vials of MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473, Lot No. 2019. The product is a kit intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.

The recall was initiated on November 2, 2020, and classified as Class II by the FDA. The specific reason for the recall is not detailed in the provided source text. The affected product was distributed worldwide, including in the United States (California and New York) and numerous international locations such as Australia, Belgium, Brazil, Germany, and Canada.

The recall was terminated on December 20, 2021. Consumers and healthcare facilities should check their inventory for this specific lot number and expiration date (05/01/2022) and contact the manufacturer for instructions on return or disposal.

The recalled product

Product
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.
Manufacturer
Chromsystems Instruments & Chemicals GmbH
Category
Medical Device — Laboratory Diagnostic Kit
Hazard
Affected units
342

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Order No. 0473
  • Lot No. 2019 (expiration 05/01/2022)

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Chromsystems Instruments & Chemicals GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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