FDA Device recall Z-0310-2022
Total Thyroxine (T4) ELISA
- FDA Device
- Class II
- ongoing
- Published 2021-12-08
On 2021-12-08 the FDA classified a Class II recall of Total Thyroxine (T4) ELISA by Drg International, citing 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 pat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0310-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-10-18 |
| Published | 2021-12-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Drg International |
| Distribution | CO, DE, NY |
Product
Total Thyroxine (T4) ELISA; REF EIA-1781
Reason
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.
Identifiers
| code_info | lot#: RN-60923 expiration date 12/31/2021; RN-60831 expiration date 12/31/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0310-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.