The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0538-2021·Announced 2020-12-16

Chromsystems Recalls MassChrom Amino Acid Analysis Plasma Control Level II

Chromsystems Instruments & Chemicals GmbH is voluntarily recalling 363 vials of MassChrom Amino Acid Analysis Plasma Control Level II 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific injuries, illnesses, or deaths, and the reason for the recall is not explicitly detailed as a high-risk pathogen or structural defect, placing it in the Moderate category per the rubric.

Plain-English summary

Chromsystems Instruments & Chemicals GmbH has voluntarily recalled 363 vials of MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472, Lot No. 2019. The recall was initiated on November 2, 2020, and is classified as Class II by the U.S. Food and Drug Administration. The specific reason for the recall is not detailed in the provided source text.

The affected product is intended for amino acid metabolic screening, confirmation of tentative diagnoses, and monitoring of treatment in individuals with metabolic disorders. The recall covers worldwide distribution, including the United States (specifically 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 the specific order and lot numbers listed above and stop using the product if it matches the recalled description.

The recalled product

Product
MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - 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
363

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. 0472
  • 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 →

Related recalls

Same manufacturer · Chromsystems Instruments & Chemicals GmbH

See all →

Same hazard · device defect

See all →

Similar recalls