Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: Recalled by DRG International, Inc. Due to Invalid Controls. The Low Control is out of...

Date: July 5, 2024
Company: DRG International, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact DRG International, Inc. directly.

Affected Products

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.

Quantity: 257 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About DRG International, Inc.

DRG International, Inc. has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report