Sperm Ab ELISA Test Kit Recall: False Negative Risk
DRG International recalls Sperm Ab ELISA test kits with model EIA-1826 due to potential false negative results. Affected kits sold worldwide, including US, NJ, and multiple international countries. Contact for remedy.
Lower-risk recall
Potential for false negative patient results.
What happened, in plain English
DRG International recalls a specific sperm antibody ELISA test kit (model EIA-1826) because it may give false negative results. This could lead to incorrect conclusions about sperm antibodies. The recall affects 211 units sold globally. Read more at govinfonow.com/recall/1629907-drg-international-inc-recalls-sperm-ab-elisa-model-catalog-number.
Source Summary by GovInfoNow · govinfonow.com/recall/1629907-drg-international-inc-recalls-sperm-ab-elisa-model-catalog-number · Updated October 21, 2026 · FDA enforcement record: FDA #Z-0082-2027
Cite this page
“Sperm Ab ELISA Test Kit Recall: False Negative Risk.” GovInfoNow, updated October 21, 2026. https://govinfonow.com/recall/1629907-drg-international-inc-recalls-sperm-ab-elisa-model-catalog-number. Based on FDA recall #Z-0082-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0082-2027%22&limit=1).
Why it’s dangerous
The test kit may produce false negative results, meaning it could incorrectly indicate the absence of sperm antibodies when they are actually present. This could lead to inaccurate medical conclusions about fertility or reproductive health.
Who’s affected
Individuals using the Sperm Ab ELISA test kit with model EIA-1826 for sperm antibody testing are affected. Those who rely on accurate results for medical decisions are at higher risk.
How to tell if you have this one
Check for the model number EIA-1826 on the test kit packaging. The lot number 320K046 and unique device identifier UDI 04048474018264 are also associated with this recall.
- Brand
DRG International- Category
Medical device
What to do — step by step
Check Product Details
Look for the model number EIA-1826 and lot number 320K046 on the test kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide - US Nationwide distribution in the state of NJ and the countries of Azerbaijan, Belgium, Czech Republic, Germany, Hungary, India, Italy, Kuwait, Russia, Spain, Ukraine.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Questions people ask
Where was this test kit sold?
The test kit was sold worldwide, including the US, New Jersey, Azerbaijan, Belgium, Czech Republic, Germany, Hungary, India, Italy, Kuwait, Russia, Spain, and Ukraine.
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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-0082-2027 (July 2, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0082-2027 to see it in context.
- Plain-language summary written by qwen3:4b on October 21, 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.