Chromsystems Recalls MassChrom Cortisol Saliva Control Level I Vials
Chromsystems is recalling 880 vials of MassChrom Cortisol, Cortisone Saliva Control Level I because the control lots may not meet stability criteria, potentially causing increased patient results.
What this means for you
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, and the hazard involves potential inaccurate test results rather than direct physical injury or a high-risk pathogen, fitting the criteria for a moderate severity recall.
Plain-English summary
Chromsystems Instruments & Chemicals GmbH is recalling 880 vials of MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349. The affected lots are Lot No. 3219 (Expiration 08/01/2021) and Lot No. 1020 (Expiration 03/01/2022). The product was distributed nationwide in North Carolina and New York.
The recall was initiated because the control lots may not meet stability criteria. This defect could result in increased results for patient samples testing for cortisone. The kit is used by patients to monitor their cortisol and cortisone levels.
Consumers and healthcare providers should stop using the affected product and contact Chromsystems Instruments & Chemicals GmbH for further instructions or a replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Chromsystems Instruments & Chemicals GmbH
- Hazard
- Affected units
- 880
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. 0349
- 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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