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Recall Observatory FDA recall evidence

Device product

DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic

Z-2410-2019

June 06, 2019

Class II

Product summary

Firm
DRG Instruments GmbH
Event
Event 83177
Status
Terminated
Classification
Class II
Quantity
8 Kits
Official record key
device-enforcement:Z-2410-2019

Official wording

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.

Code information: Lot Number:315K029

Distribution pattern: Distribution to Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.