Device product
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.
Z-2622-2024
Product summary
- Event
- Event 95021
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 257 units
- Official record key
device-enforcement:Z-2622-2024
Official wording
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 information: Model/Catalog Number: SLV-3013; UDI-DI: 04048474030136; Lot Nymbers: 66K014 and 66K123.
Distribution pattern: US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.
Derived failure modes
-
Unknown
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.