FDA recall Z-2622-2024

DRG International, Inc. · Class III · device

Product

Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.

Reason for recall

Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results to patients.

Distribution

US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.

Key facts

Status
Ongoing
Initiation date
2024-07-05
Report date
2024-08-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Springfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2622-2024