Chromsystems Saliva Calibrator Set Recalled for Stability Issues
Chromsystems is recalling 6PLUS1 Multilevel Saliva Calibrator Sets because they may not meet stability criteria, potentially causing increased cortisone results in patient 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 readings) rather than a direct physical injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Chromsystems Instruments & Chemicals GmbH is recalling 148 package units of the 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039. The affected lots are Lot 3219 (expiration 08/01/2021) and Lot 1020 (expiration 03/01/2022). These kits are used to monitor cortisol and cortisone levels in patients.
The recall was initiated because the calibrator lots may not meet stability criteria. This defect could result in increased results for patient samples regarding cortisone levels. 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 calibrator sets immediately. Users should contact Chromsystems Instruments & Chemicals GmbH for further instructions on how to return or dispose of the product.
The recalled product
- Product
- 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.
- Manufacturer
- Chromsystems Instruments & Chemicals GmbH
- Affected units
- 148
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. 73039
- Lot 3219 (expiration 08/01/2021) and Lot 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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