BioCheck T4 EIA Kit Recall: Failed Controls Due to Shelf-Life Issues
BioCheck recalls T4 EIA Kit (BC-100: RN-60831/RN-60923) due to shelf-life issues causing failed controls. This affects in vitro diagnostic tests for thyroid disorders.
Lower-risk recall
Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.
Contact the company
What happened, in plain English
BioCheck is recalling T4 EIA Kits with specific lot numbers because they don't meet shelf-life standards, which can cause failed controls in thyroid tests. This means the kits might not work properly if used after their expiration date. Read more at govinfonow.com/recall/61679-biocheck-t4-eia-kit-recall-failed-controls-due-to-shelf.
Source Summary by GovInfoNow · govinfonow.com/recall/61679-biocheck-t4-eia-kit-recall-failed-controls-due-to-shelf · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0214-2022
Cite this page
“BioCheck T4 EIA Kit Recall: Failed Controls Due to Shelf-Life Issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61679-biocheck-t4-eia-kit-recall-failed-controls-due-to-shelf. Based on FDA recall #Z-0214-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0214-2022%22&limit=1).
Why it’s dangerous
The kits may not meet shelf-life standards, leading to failed controls. This means the test results could be inaccurate if the kits are used after their expiration date, potentially affecting thyroid disorder diagnoses.
Who’s affected
Lab users and healthcare professionals who purchased the T4 EIA Kit (BC-1007) with lot numbers RN-60831 or RN-60923. Those using the kits for thyroid testing are most at risk.
How to tell if you have this one
Check the lot number on the kit label. The affected kits have lot numbers RN-60831 or RN-60923 and are sold as T4 EIA Kit (BC-1007) for in vitro diagnostic use.
- Brand
BioCheck- Category
Medical device
What to do — step by step
Check Kit Lot Number
Look for lot numbers RN-60831 or RN-60923 on the T4 EIA Kit (BC-1007) label.
Where it went and when
Where it was distributed
Distributed in 5 states, and outside the U.S.
FDA distribution: “US Distribution to states of: MI, FL, NJ, OH, CA; and OUS (foreign) distribution to countries of: Spain, Taiwan and Nigeria” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Michigan, New Jersey, Ohio.
Recall timeline
FDA terminated this recall 3.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using this kit?
No action is required beyond checking the lot number. The recall does not require immediate disposal or replacement.
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Where this comes from
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-0214-2022 (October 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0214-2022 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.