Health product recall

Salivary Progesterone HS ELISA (2019-05-20)

Starting date:
May 20, 2019
Posting date:
June 14, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70191

Last updated: 2019-06-14

Affected Products

Salivary Progesterone HS ELISA

Reason

The user of this assay may observe a higher percentage of samples with low results. Saliva samples in the low measuring range of the kit (less than 20 pg/mL) were assayed and producing a significantly lower result. Samples above 50 pg/mL were found to be accurate. This issue is caused by a component of the calibrator's matrix that has lost activity over time. It was found to be accurate.

Affected products

Salivary Progesterone HS ELISA

Lot or serial number

315K029

Model or catalog number

SLV-5911

Companies
Manufacturer

DRG INTERNATIONAL, INC.

841 MOUNTAIN AVENUE

SPRINGFIELD

07081

New Jersey

UNITED STATES