Recall Z-2410-2019
DRG Instruments GmbH · initiated June 6, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
Codes / lots: Lot Number:315K029
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
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 affected lot should be checked again carefully. If results are lower than expected samples should be re-run again. 6. Please tell us if you have experienced any problem with this lot and specify the details. Reply to DRG (email: qa@drg-international.com and copy drgsupport.@drginternational.com).
Details
- Recall number
- Z-2410-2019
- Initiated
- June 6, 2019
- Terminated
- May 11, 2020
- Product code
- JLS – Radioimmunoassay, Progesterone
- Quantity
- 8 Kits
- Distribution
- Distribution to Canada
- Recalling firm
- DRG Instruments GmbH, Marburg