Lower riskMedical device recall · FDA · Published July 5, 2024
DRG Salivary Testosterone ELISA SLV-3013: Invalid Controls Cause Delayed Results
DRG International recalls Salivary Testosterone ELISA model SLV-3013 due to invalid controls causing repeated tests and delayed patient results. Affected units have specific lot numbers.
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.
“DRG Salivary Testosterone ELISA SLV-3013: Invalid Controls Cause Delayed Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54692-drg-salivary-testosterone-elisa-slv-3013-invalid-controls-cause-delayed. Based on FDA recall #Z-2622-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2622-2024%22&limit=1).
The FDA announced on July 5, 2024, that DRG International, Inc. is recalling its Salivary Testosterone ELISA kits due to invalid controls. The hazard involves low control levels being out of range, which causes invalid runs and delays in reporting results to patients.
How to tell if you have it
Brand: DRG International
Product Name: Salivary Testosterone ELISA
Model/Catalog Number: SLV-3013
Lot Numbers: 66K014 and 66K123
Units affected: 257
The hazard
The recall cites invalid controls where the Low Control is out of range and too high. This issue causes invalid runs that result in repeating the runs and delays for reporting results to patients.
Context
GovInfoNow's records show DRG International, Inc. has had five other recalls since October 18, 2021. Recent similar recalls include a T4 Total ELISA Kit recall on June 4, 2025, and a DRG Hybrid-XL Insulin Recall on October 7, 2024. Other recent recalls of similar products include a Tosoh ST AIA-Pack Testosterone Recall (June 12, 2026) and a Stago STA Liatest Free Protein S recall (February 4, 2026).
How to tell if you have this one
Check for the model number SLV-3013 on the product. Affected units have lot numbers 66K014 or 66K123. The product is used for saliva testosterone testing in labs.
Brand
DRG International
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for lot numbers 66K014 or 66K123 on the product packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Illinois, Minnesota, Pennsylvania, Utah, Virginia.
Recall timeline
FDA published this recall 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2622-2024 (July 5, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2622-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.