DRG Salivary Progesterone ELISA Kit Recalled for Low Result Bias
DRG Instruments GmbH is recalling 8 kits of Salivary Progesterone HS ELISA due to significantly lower results in low measuring ranges.
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, which typically corresponds to a moderate severity score when no hospitalizations or serious injuries are reported, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
DRG Instruments GmbH is recalling 8 kits of the DRG Salivary Progesterone HS ELISA (REF: SLV-5911), an in vitro diagnostic device used for the determination of progesterone in human saliva. The recall involves Lot Number 315K029, which was distributed to Canada.
The recall was initiated because the assay may observe a higher percentage of samples with low results. Specifically, saliva samples in the low measuring range of the kit (< 20 pg/ml) were assayed and produced significantly lower results than expected.
Consumers and healthcare providers who possess this specific lot of the product should stop using it and contact the manufacturer for further instructions.
The recalled product
- Product
- DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
- Manufacturer
- DRG Instruments GmbH
- Hazard
- Affected units
- 8
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 (1)
- Lot Number:315K029
Distribution
Distribution scope not specified by the agency.
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