Salivary Estradiol ELISA recall
Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
Why was Salivary Estradiol ELISA recalled?
Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 68K056 Exp. Date 2017-05
- Product
- Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
- Recalling firm
- DRG Instruments GmbH
- Quantity
- 169 kits
- Distribution
- NJ; Germany, Belgium, Spain & Germany
- Recall date
- August 22, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)