Chromsystems MassChrom Amino Acid Kit May Affect Test Results
Chromsystems recalls MassChrom Amino Acid Analysis Plasma Control Level I kits that may impact test results due to stability issues. Affected kits have Order No. 0471 and Lot No. 2019 (expiring 05/01/2022).
Lower-risk recall
Products do not meet stability criteria and may impact results.
Contact the company
What happened, in plain English
Chromsystems is recalling certain amino acid analysis plasma control kits because they may not stay stable long enough to give accurate test results. This could lead to incorrect diagnoses or treatment monitoring for people with metabolic disorders. Read more at govinfonow.com/recall/64002-chromsystems-masschrom-amino-acid-kit-may-affect-test-results.
Source Summary by GovInfoNow · govinfonow.com/recall/64002-chromsystems-masschrom-amino-acid-kit-may-affect-test-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0537-2021
Cite this page
“Chromsystems MassChrom Amino Acid Kit May Affect Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64002-chromsystems-masschrom-amino-acid-kit-may-affect-test-results. Based on FDA recall #Z-0537-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0537-2021%22&limit=1).
Why it’s dangerous
The kits may not stay stable long enough to provide accurate results. This could lead to incorrect diagnoses or treatment monitoring for people with metabolic disorders, but the risk is not immediate or life-threatening.
Who’s affected
Individuals using the MassChrom Amino Acid Analysis Plasma Control Level I kit for amino acid metabolic screening or metabolic disorder monitoring are most at risk. The recall affects kits with Order No. 0471 and Lot No. 2019.
How to tell if you have this one
Check for Order No. 0471 and Lot No. 2019 (expiring 05/01/2022) on the kit packaging. The kit is used for amino acid metabolic screening and metabolic disorder monitoring.
- Brand
Chromsystems- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0536-2021 | 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.; Order No. 75128, Lots No. 2219 (expiration 05/01/2022) and 2320 (expiration 06/01/2023) | 200 packaging units |
| Z-0537-2021 | 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.; Order No. 0471, Lot No. 2019 (expiration 05/01/2022) | 362 vials |
| Z-0538-2021 | 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.; Order No. 0472, Lot No. 2019 (expiration 05/01/2022) | 363 vials |
| Z-0539-2021 | 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.; Order No. 0473, Lot No. 2019 (expiration 05/01/2022) | 342 vials |
What to do — step by step
Check Kit Details
Look for Order No. 0471 and Lot No. 2019 (expiring 05/01/2022) on the product packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 2 states.
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, New York.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0537-2021 (November 2, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0537-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.