Chromsystems 6PLUS1 Saliva Calibrator Set Recall: Inaccurate Cortisol Results
Chromsystems recalls specific lots of 6PLUS1 Multilevel Saliva Calibrator Sets due to potential inaccurate cortisol and cortisone test results. Affected units may need replacement.
Lower-risk recall
Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
Contact the company
What happened, in plain English
Chromsystems is recalling certain lots of their 6PLUS1 Multilevel Saliva Calibrator Sets because they might give incorrect cortisol and cortisone test results. This could lead to inaccurate health monitoring for patients using the kit. Read more at govinfonow.com/recall/64045-chromsystems-6plus1-saliva-calibrator-set-recall-inaccurate-cortisol-results.
Source Summary by GovInfoNow · govinfonow.com/recall/64045-chromsystems-6plus1-saliva-calibrator-set-recall-inaccurate-cortisol-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0521-2021
Cite this page
“Chromsystems 6PLUS1 Saliva Calibrator Set Recall: Inaccurate Cortisol Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64045-chromsystems-6plus1-saliva-calibrator-set-recall-inaccurate-cortisol-results. Based on FDA recall #Z-0521-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0521-2021%22&limit=1).
Why it’s dangerous
The calibrator lots may not meet stability criteria, which means the test results for cortisol and cortisone could be higher than they should be. This could lead to incorrect health assessments if the kit is used for patient monitoring.
Who’s affected
Patients using the 6PLUS1 Multilevel Saliva Calibrator Set for cortisol and cortisone testing are affected. Those with the specific lots mentioned in the recall are at risk of inaccurate test results.
How to tell if you have this one
Check for the product name '6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva' with Order No. 73039. The affected lots are Lot 3219 (expires 08/01/2021) and Lot 1020 (expires 03/01/2022).
- Brand
Chromsystems- Category
Medical device
All 3 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
Completed- Distribution
US Nationwide distribution in the states of NC and NY.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0521-2021 | 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.; Order No. 73039, Lot 3219 (expiration 08/01/2021) and Lot 1020 (Expiration 03/01/2022) | 148 package units |
| Z-0522-2021 | MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.; Order No. 0349, Lot No. 3219 (Expiration 08/01/2021) and Lot No. 1020 (Expiration 03/01/2022) | 880 vials |
| Z-0523-2021 | MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.; Order No. 0350, Lot No. 3219 (Expiration 08/01/2021) and Lot No. 1020 (Expiration 03/01/2022) | 850 vials |
What to do — step by step
Check Product Lot Number
Identify the lot number on your calibrator set to see if it's Lot 3219 (expires 08/01/2021) or Lot 1020 (expires 03/01/2022).
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
FDA distribution: “US Nationwide distribution in the states of NC and NY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: New York, North Carolina.
Recall timeline
FDA published this recall 41 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-0521-2021 (October 29, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0521-2021 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.