DRG Salivary Progesterone HS ELISA- IVD for the recall
DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
Why was DRG Salivary Progesterone HS ELISA- IVD for the recalled?
Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva samples in the low measuring range of the kit {< 20 pg/ml) were assayed and producing a significantly lower result.
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 Number:315K029
- Product
- DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
- Recalling firm
- DRG Instruments GmbH
- Quantity
- 8 Kits
- Distribution
- Distribution to Canada
- Recall date
- September 4, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)