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).
Products do not meet stability criteria and may impact results.
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.
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.
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.
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.
Look for Order No. 0471 and Lot No. 2019 (expiring 05/01/2022) on the product packaging.
The kits do not meet stability criteria and may impact test results, potentially leading to incorrect diagnoses or treatment monitoring for metabolic disorders.
Check the packaging for Order No. 0471 and Lot No. 2019 (expiring 05/01/2022). If you have these details, contact Chromsystems for guidance.
The recall states the kits may impact test results but does not mention any risk of serious injury or immediate danger.
We’ve drafted a message you can send Chromsystems to request your refund or repair — edit it as you like.
Subject: Recall Z-0537-2021 — Chromsystems Chromsystems Hello, I own a Chromsystems that is covered by recall Z-0537-2021 from Chromsystems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
