Recall Z-2410-2019 ยท JLS Radioimmunoassay, Progesterone
DRG Instruments GmbH
DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
| Date | Jun 6, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | DRG International issued notification letter via email dated 5/22/19 advising of the problem, health risk and Action to be taken by Distributors and End-users: 1. We kindly ask you to immediately examine your stock and promptly quarantine these products. 2. Please send back or discard all unused kits 3. Please use the attached response form, fill, sign and send back to us 4. Please inform your customers and forward this letter and notice to persons who received the affected lot and request they fill out the form and return at once. 5. Patient samples that have been determined with the affecte |
| Quantity | 8 Kits |
| Distribution | Distribution to Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.