DRG International, Inc. Recall 95021
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.
DRG International, Inc. Recall 95021 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2622-2024 |
| Event ID | 95021 |
| Event 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA. |
| Quantity | 257 units |
| Recall 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. |
| Device Classification | 20240821 |
| Device Code Info | Model/Catalog Number: SLV-3013; UDI-DI: 04048474030136; Lot Nymbers: 66K014 and 66K123. |
| Center Classification Date | 20240815 |
| Recall Initiation Date | 20240705 |
| Recalling Firm | DRG International, Inc. |
| Initial Notification | Letter |
| Similar To |