Chromsystems recalls Cortisol and Cortisone Saliva Control Level II kits with potential for inaccurate patient test results due to stability issues. Affected lots expired by 08/01/2021 and 03/01/2022.
Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
Chromsystems is recalling its Cortisol and Cortisone Saliva Control Level II test kits because some batches may produce inaccurate patient results. This could lead to incorrect health assessments if used without proper validation.
The test kits may not stay stable long enough to produce accurate results. This could cause patient samples to show higher cortisone levels than they actually have, leading to incorrect health conclusions.
Patients using the test kits for cortisol and cortisone monitoring. Those who purchased the specific lots (3219 expiring 08/01/2021 or 1020 expiring 03/01/2022) are most at risk.
Check the lot number on the kit packaging. Affected lots are 3219 (expires 08/01/2021) and 1020 (expires 03/01/2022).
Look for the lot number on the product packaging to determine if it's affected (3219 or 1020).
The kits may not meet stability criteria, which could lead to increased results of patient samples for cortisone.
The recall record does not specify a remedy, so check the lot number and contact Chromsystems for further instructions.
The recall indicates potential for inaccurate results, not physical harm. This is a low-risk issue related to test accuracy.
We’ve drafted a message you can send Chromsystems to request your refund or repair — edit it as you like.
Subject: Recall Z-0523-2021 — Chromsystems Chromsystems Hello, I own a Chromsystems that is covered by recall Z-0523-2021 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.
