DRG International, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2622-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: July 5, 2024

Date Posted: August 21, 2024

Recall Number: Z-2622-2024

Event ID: 95021

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.

Status: Ongoing

Product Quantity: 257 units

Code Information:

Model/Catalog Number: SLV-3013; UDI-DI: 04048474030136; Lot Nymbers: 66K014 and 66K123.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated