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.
Reported: December 9, 2020 Initiated: October 29, 2020 #Z-0523-2021
Product Description
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.
Reason for Recall
Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
Details
- Recalling Firm
- Chromsystems Instruments & Chemicals GmbH
- Units Affected
- 850 vials
- Distribution
- US Nationwide distribution in the states of NC and NY.
- Location
- Grafelfing, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Chromsystems Instruments & Chemicals GmbH. Units affected: 850 vials.
Why was this product recalled? ▼
Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 9, 2020. Severity: Moderate. Recall number: Z-0523-2021.
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