Biomerieux recalls two batches of VIDAS Varic: Zoster IgG antibody kits due to potential invalid calibration causing delayed results or false positives. Affected kits include US Model 30217-01 Lot 1007410330 and 1007393380.
Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient's sample result or a valid calibration may lead to a false positive patient result.
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Contact the company
📍Recalling firmbioMerieux, Inc.100 Rodolphe St · Durham, NC 27712-9402
“Biomerieux VIDAS VZG Kit Recall: Invalid Calibration Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/66393-biomerieux-vidas-vzg-kit-recall-invalid-calibration-risk. Based on FDA recall #Z-1107-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1107-2020%22&limit=1).
The FDA announced on Dec. 10, 2019, that bioMerieux, Inc. is recalling VIDAS Varicella Zoster IgG antibody IVD kits due to potential invalid calibration or false positive results. The agency issued recall number Z-1107-2020 for the Class II device.
Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient's sample result or a valid calibration may lead to a false positive patient result, according to the FDA.
Context
GovInfoNow's records show Biomerieux Inc has 36 other recalls on record since July 12, 2017. Other recent recalls of similar products include Sperm Ab ELISA Test Kit Recall (July 2, 2026), BioFire Joint Infection Panel Recall (April 22, 2026), and Bioporto ProNephro AKI Reagent Kit Recall (May 18, 2026).
How to tell if you have this one
Check the product label for US Model 30217-01 and lot numbers 1007410330 or 1007393380. The kits are used for medical testing of varicella-zoster virus antibodies.
Brand
Biomerieux
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Label
Look for US Model 30217-01 and lot numbers 1007410330 or 1007393380 on the product label.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Distributed nationwide and 9 units to Biomerieux Canada.” 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 terminated this recall 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-1107-2020 (December 10, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1107-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.