FDA Enforcement
Class III
Ongoing
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.
Recall: Z-2622-2024
·
Reported August 21, 2024
Enforcement
- Recall Number
- Z-2622-2024
- Event ID
- 95021
- Classification
- Class III
- Status
- Ongoing
- Product Type
- Devices
- Firm
- DRG International, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 21, 2024
- Initiation Date
- July 5, 2024
- Classification Date
- August 15, 2024
- Address
- 841 Mountain Ave, Springfield, NJ, 07081-3437, United States
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.
Reason
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.
Code Info
Model/Catalog Number: SLV-3013; UDI-DI: 04048474030136; Lot Nymbers: 66K014 and 66K123.
Distribution
US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.
Quantity
257 units