Z-2410-2019 Class II Terminated
FDA device recall Z-2410-2019 was initiated by DRG Instruments GmbH on June 6, 2019 and is designated Class II. 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 lo… The recall status is terminated (terminated May 11, 2020). Affected quantity: 8 Kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2019
- Initiation Date
- June 6, 2019
- Termination Date
- May 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 Kits
Product Description
DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
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.
Distribution Pattern
Distribution to Canada
Code Information
Lot Number:315K029