Reported Dec 9, 2020 · Completed
6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used…
Chromsystems Instruments & Chemicals GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Chromsystems Instruments & Chemicals GmbH · Am Haag 12 · Grafelfing, N/A · N/A
Is this the product you have?
- 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 -
- Product UsageThe kit is used as a test for patients to monitor their cortisol and cortisone levels
- Lot codes and dates
- Order No. 73039, Lot 3219 (expiration 08/01/2021) and Lot 1020 (Expiration 03/01/2022)
- Amount recalled
- 148 package units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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