Product Name: Salivary Testosterone ELISA Model/Catalog Number:… — Class III medical device recall Z-2622-2024
Ongoing recall by DRG International, Inc., reported 2024-08-21, distributed nationwide. Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in rep
| Recall number | Z-2622-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DRG International, Inc., Springfield, NJ, United States |
| Recall initiated | 2024-07-05 |
| Classified | 2024-08-15 |
| Reported by FDA | 2024-08-21 |
| Distributed | Nationwide (US) |
| Quantity | 257 units |
| UPC / GTIN / UDI-DI | 04048474030136 |
| Model numbers | SLV-3013 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2622-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.