Recall archive / FDA device enforcement
Total Thyroxine (T4) ELISA; REF EIA-1781 — FDA record Z-0310-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 18, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- DRG International, Inc.
- Quantity
- 314 total (270 US)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0310-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | lot#: RN-60923 expiration date 12/31/2021; RN-60831 expiration date 12/31/2021 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG, RU/UA, NI, DO, NG, EG & CM
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 8, 2021
- Recall initiation date
- Oct 18, 2021
- Center classification date
- Nov 29, 2021
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.