Chromsystems Recalls MassChrom Cortisol and Cortisone Saliva Control Level II Kits
Chromsystems is recalling MassChrom Cortisol, Cortisone Saliva Control Level II kits because control lots may not meet stability criteria, potentially causing increased results for patient cortisone samples.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential for inaccurate test results (increased cortisone values) rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Chromsystems Instruments & Chemicals GmbH is recalling 850 vials of MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350. The affected lots are Lot No. 3219 (Expiration 08/01/2021) and Lot No. 1020 (Expiration 03/01/2022). These kits are used to monitor cortisol and cortisone levels in patients.
The recall was initiated because the control lots may not meet stability criteria. This issue could result in increased results for patient samples specifically for cortisone. The products were distributed nationwide in the United States, specifically in the states of North Carolina and New York.
Consumers and healthcare providers should stop using the affected kits and contact Chromsystems Instruments & Chemicals GmbH for further instructions or a replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Chromsystems Instruments & Chemicals GmbH
- Hazard
- Affected units
- 850
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Order No. 0350
- Lot No. 3219 (Expiration 08/01/2021) and Lot No. 1020 (Expiration 03/01/2022)
Distribution
Part of a larger recall action
This product is one of 3 recalled by Chromsystems Instruments & Chemicals GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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