Chromsystems recalls 3PLUS1 Multilevel Plasma Calibrator Set (Order No. 75128) due to stability problems that may impact amino acid metabolic test results. Affected units include specific lots with expiration dates.
Products do not meet stability criteria and may impact results.
Chromsystems is recalling a plasma calibrator set used for amino acid metabolic testing because it may not stay stable, leading to inaccurate test results. This affects individuals using the kit for metabolic disorder diagnosis or treatment monitoring.
The calibrator set may not meet stability criteria, which can cause test results to be inaccurate. This could lead to incorrect diagnoses or treatment decisions for individuals with metabolic disorders.
Individuals using the 3PLUS1 Multilevel Plasma Calibrator Set for amino acid metabolic screening, diagnosis confirmation, or treatment monitoring are affected. Those with metabolic disorders are most at risk due to potential inaccurate test results.
Check for the product name '3PLUS1 Multilevel Plasma Calibrator Set' with Order No. 75128. Affected units include Lot No. 2219 (expires 05/01/2022) and Lot No. 2320 (expires 06/01/2023).
Identify the order number and lot numbers to confirm if your unit is affected.
The 3PLUS1 Multilevel Plasma Calibrator Set does not meet stability criteria and may impact amino acid metabolic test results.
The recall record does not specify a remedy, so check the product details to see if it is affected.
Lot No. 2219 (expires 05/01/2022) and Lot No. 2320 (expires 06/01/2023).
We’ve drafted a message you can send Chromsystems to request your refund or repair — edit it as you like.
Subject: Recall Z-0536-2021 — Chromsystems Chromsystems Hello, I own a Chromsystems that is covered by recall Z-0536-2021 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.
