DRG Instruments Recalls Salivary Estradiol ELISA Kits Due to Measurement Errors
DRG Instruments GmbH is recalling 169 Salivary Estradiol ELISA kits because poor differentiation between standards may cause lower recovery of estradiol levels.
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 inaccurate diagnostic results without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
DRG Instruments GmbH is recalling 169 units of the Salivary Estradiol ELISA (REF SLV-4188). This in vitro diagnostic product is used for the quantitative measurement of active free estradiol in saliva. The affected lot is # 68K056 with an expiration date of 2017-05.
The recall was initiated because the kit exhibits poor differentiation between Standard 0 and Standard 1, which results in lower recovery of salivary estradiol levels. This defect may lead to inaccurate test results.
The product was distributed in New Jersey and in Germany, Belgium, and Spain. Users of the affected kits should stop using them and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
- Manufacturer
- DRG Instruments GmbH
- Affected units
- 169
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 # 68K056 Exp. Date 2017-05
Distribution
Distribution scope not specified by the agency.
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