FDAFDA · Food and drugs·Recall number Z-2622-2024
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.
Published August 21, 2024 · Recall initiated: July 5, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- DRG International, Inc.
- Distributor
- US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.
- Lot
- Model/Catalog Number: SLV-3013; UDI-DI: 04048474030136; Lot Nymbers: 66K014 and 66K123.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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