Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0536-2021·Announced 2020-12-16

Chromsystems 3PLUS1 Multilevel Plasma Calibrator Set Recalled for Stability Issues

Chromsystems is recalling 3PLUS1 Multilevel Plasma Calibrator Sets because they do not meet stability criteria, which may impact test 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 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. The hazard is a failure to meet stability criteria which may impact results, but no specific injuries, illnesses, or deaths are reported in the source text, fitting the criteria for a moderate severity recall involving potential impact on diagnostic accuracy without immediate physical harm.

Plain-English summary

Chromsystems Instruments & Chemicals GmbH is recalling the 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128. The affected lots are 2219 (expiration 05/01/2022) and 2320 (expiration 06/01/2023). A total of 200 packaging units are involved in this recall.

The recall was initiated because the products do not meet stability criteria, which may impact results. 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.

The product was distributed worldwide, including in the United States (California and New York) and in 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 products and contact the manufacturer for instructions.

The recalled product

Product: 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - 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 Reagent
Hazard: stability-failure
inaccurate-results
Affected units: 200

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. 75128
Lots No. 2219 (expiration 05/01/2022) and 2320 (expiration 06/01/2023)

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
Laboratory Control Material Recalled for Insufficient Glycine Concentration
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 Recalls MassChrom Amino Acid Analysis Plasma Control Level II
FDA (Devices) · 2020-12-16
High
Chromsystems MassChrom Amino Acid Analysis Plasma Control Level I Recalled
FDA (Devices) · 2020-12-16

Same hazard · stability failure