Total Thyroxine — Class II medical device recall Z-0310-2022
Ongoing recall by DRG International, Inc., reported 2021-12-08, distributed in NY. Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The
| Recall number | Z-0310-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DRG International, Inc., Springfield, NJ, United States |
| Recall initiated | 2021-10-18 |
| Classified | 2021-11-29 |
| Reported by FDA | 2021-12-08 |
| Distributed | NY |
| Lot numbers | RN-60831, RN-60923 |
| Model numbers | EIA-1781 |
| Expiration dates | 2021-12-31 |
Product
Total Thyroxine (T4) ELISA; REF EIA-1781
Reason for recall
Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of patient samples.
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-0310-2022. 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.