Diasorin Parvovirus B19 IgG EIA Kit Recall: Incorrect Label Value Risk
Diasorin recalls Parvovirus B19 IgG EIA kit (Part No. V519IGUS) due to incorrect label value. This may affect test accuracy. No remedy specified in recall notice.
Lower-risk recall
Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value
Contact the company
What happened, in plain English
Diasorin is recalling a specific Parvovirus B19 IgG EIA test kit because the label inside the box lid has an incorrect Lot Specific Constant value. This could lead to inaccurate test results if used. Read more at govinfonow.com/recall/64691-diasorin-parvovirus-b19-igg-eia-kit-recall-incorrect-label-value.
Source Summary by GovInfoNow · govinfonow.com/recall/64691-diasorin-parvovirus-b19-igg-eia-kit-recall-incorrect-label-value · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2936-2020
Cite this page
“Diasorin Parvovirus B19 IgG EIA Kit Recall: Incorrect Label Value Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64691-diasorin-parvovirus-b19-igg-eia-kit-recall-incorrect-label-value. Based on FDA recall #Z-2936-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2936-2020%22&limit=1).
Why it’s dangerous
The incorrect Lot Specific Constant value on the label inside the box lid could cause the test kit to produce inaccurate results. This might lead to wrong conclusions about a person's parvovirus B19 status.
Who’s affected
People who purchased the Parvovirus B19 IgG EIA kit with Part No. V519IGUS from the manufacturer. Those using the kit for blood testing may be at risk of inaccurate results.
How to tell if you have this one
Check for the Parvovirus B19 IgG EIA kit with Part No. V519IGUS. The kit was sold with Lot 71440040AA. Look for the incorrect label value inside the box lid.
- Brand
Diasor:in- Category
Medical device
What to do — step by step
Check Kit Label
Inspect the label inside the box lid for the correct Lot Specific Constant value.
Where it went and when
Where it was distributed
Distributed in 11 states, and outside the U.S.
FDA distribution: “NJ, WI, NY, NC, MN, CA, IL, VA, MA, MI, CT Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Connecticut, Illinois, Massachusetts, Michigan, Minnesota, New Jersey, New York, North Carolina, Virginia, Wisconsin.
Recall timeline
FDA published this recall 54 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this kit dangerous to use?
The recall is due to a potential for inaccurate test results, not a physical hazard. The kit can still be used but may not give correct results.
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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-2936-2020 (July 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2936-2020 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.