Agency classClass IIOur severity:High FDA (Devices)·Z-0537-2021·Announced 2020-12-16

Chromsystems MassChrom Amino Acid Analysis Plasma Control Level I Recalled

Chromsystems Instruments & Chemicals GmbH is recalling MassChrom Amino Acid Analysis Plasma Control Level I kits because they do not meet stability criteria and may impact results.

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 agency classified this as a Class II recall, and the hazard involves potential impact on diagnostic results for a medical device, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Chromsystems Instruments & Chemicals GmbH is recalling MassChrom Amino Acid Analysis Plasma Control Level I kits, Order No. 0471, Lot No. 2019 (expiration 05/01/2022). The recall involves 362 vials. The product is 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 because the products do not meet stability criteria and may impact results. The agency classified this as a Class II recall.

The product was distributed worldwide, including in the United States (California and New York), Australia, Belgium, Brazil, Germany, Finland, France, Greece, Israel, Italy, Canada, Croatia, Kuwait, Austria, Russia, Switzerland, South Africa, Taiwan, Turkey, and the United Arab Emirates. Users should stop using the affected product and contact the manufacturer for instructions.

The recalled product

Product: MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - 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 Reagents
Hazard: mis-labeling
inaccurate-results
Affected units: 362

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. 0471
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 →

Same manufacturer · Chromsystems Instruments & Chemicals GmbH

See all →

High
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FDA (Devices) · 2022-07-13
High
Medical Laboratory Control Material Recalled for Insufficient Glycine Concentration
FDA (Devices) · 2022-07-13
High
Chromsystems Recalls MassChrom Amino Acid Analysis Plasma Control Level III
FDA (Devices) · 2020-12-16
Moderate
Chromsystems 3PLUS1 Multilevel Plasma Calibrator Set Recalled for Stability Issues
FDA (Devices) · 2020-12-16
Moderate
Chromsystems Recalls MassChrom Amino Acid Analysis Plasma Control Level II
FDA (Devices) · 2020-12-16

Same hazard · mis labeling