Z-2622-2024 Class III Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 21, 2024
- Initiation Date
- July 5, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 257 units
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.
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.
Distribution Pattern
US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.
Code Information
Model/Catalog Number: SLV-3013; UDI-DI: 04048474030136; Lot Nymbers: 66K014 and 66K123.