Lower riskMedical device recall · FDA · Published October 18, 2021
DRG Total Thyroxine ELISA Recall: Expired Product May Delay Diagnosis
DRG International recalls two lots of Total Thyroxine ELISA tests that expired before their shelf life, potentially delaying thyroid diagnosis and using patient samples.
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.
“DRG Total Thyroxine ELISA Recall: Expired Product May Delay Diagnosis.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61662-drg-total-thyroxine-elisa-recall-expired-product-may-delay-diagnosis. Based on FDA recall #Z-0310-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0310-2022%22&limit=1).
The FDA announced on Oct. 18, 2021, that DRG International, Inc. is recalling Total Thyroxine (T4) ELISA kits due to shelf life failures that may delay diagnosis. The agency issued recall number Z-0310-2022 for the voluntary Class II action.
How to tell if you have it
Brand: DRG International
Product: Total Thyroxine (T4) ELISA; REF EIA-1781
Lot RN-60923, expiration date 12/31/2021
Lot RN-60831, expiration date 12/31/2021
The hazard
The firm identified two lots that do not meet product shelf life, resulting in failed Controls. According to the FDA, the clinical impact may be a delay in diagnosis and a consumption of patient samples.
Context
GovInfoNow's records show DRG International, Inc. has had six other recalls since Dec. 21, 2021, including a July 2, 2026, Sperm Ab ELISA Test Kit recall for false negative risk and a June 4, 2025, T4 Total ELISA Kit recall regarding incorrect expiration dates. Other recent recalls of similar products include the Nov. 3, 2025, GET TESTED Thyroid TSH Test recall for distribution without premarket approval and the Nov. 21, 2025, Roche Elecsys Anti-TSHR Assay recall for inconsistent results risk.
How to tell if you have this one
Check for lot numbers RN-60923 (expires 12/31/2021) or RN-60831 (expires 12/31/2021) on the Total Thyroxine ELISA tests.
Brand
DRG International
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Expiration Date
Look for lot numbers RN-60923 or RN-60831 with expiration dates of 12/31/2021.
Where it went and when
Where it was distributed
Distributed in New York, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Domestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG, RU/UA, NI, DO, NG, EG & CM” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New York.
Recall timeline
FDA published this recall 51 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0310-2022 (October 18, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0310-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.