FDA recall Z-2410-2019

Product

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

Distribution to Canada

Key facts

Status

Terminated

Initiation date

2019-06-06

Report date

2019-09-04

Termination date

2020-05-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marburg, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2410-2019