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.

Products do not meet stability criteria and may impact results.

Recall #: Z-0537-2021
Affected scope: 362 vials
Initiated: November 2, 2020

Compiled from official public sources by the publisher. · Updated September 2026

Chromsystems Instruments & Chemicals GmbH recalled MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The… - a moderate-severity action.

MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The… was recalled by Chromsystems Instruments & Chemicals GmbH in December 16, 2020. Reason: Products do not meet stability criteria and may impact results.. Check the official notice for the remedy. Verify recall #Z-0537-2021 with the FDA Devices before acting.

The recall

Chromsystems Instruments & Chemicals GmbH issued this moderate-severity FDA Devices recall-Products do not meet stability criteria and may impact results..

Moderate
severity level: Class II
classification: December 16, 2020
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0537-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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.

Reason for recall

Products do not meet stability criteria and may impact results.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0537-2021
Date reported	December 16, 2020
Date initiated	November 2, 2020
Recalling firm	Chromsystems Instruments & Chemicals GmbH
Firm location	Grafelfing, N/A
Affected scope	362 vials
Distribution	Worldwide distribution - US Nationwide distribution in the states of CA and NY; The countries of Australia, Belgium, Brazil, Germany, Finland, France, Greece, Israel, Italy, Canada, Croatia, Kuwait, Austria, Russia, Switzerland, South Afri…

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0537-2021) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Products do not meet stability criteria and may impact results.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on December 16, 2020. Severity: Moderate. Recall number: Z-0537-2021.

Where was the recalled product distributed? ▼

Distribution: Worldwide distribution - US Nationwide distribution in the states of CA and NY; The countries of Australia, Belgium, Brazil, Germany, Finland, France, Greece, Israel, Italy, Canada, Croatia, Kuwait, Austria, Russia, Switzerland, South Africa, Taiwan, Turkey, and United Arab Emirates..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported December 16, 2020. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026