Reported Feb 19, 2020 · Terminated

VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit

bioMerieux, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: bioMerieux, Inc. · 100 Rodolphe St · Durham, NC · 27712-9402

Is this the product you have?

  • VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
Lot codes and dates
  • US Model 30217-01 Lot 1007410330 and 1007393380
Amount recalled
1,218 US units total (726 US, 492 OUS)

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 16, 2021 · Data as of Sep 19, 5:25 PM UTC

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