Reported Jan 31, 2024 · Ongoing

DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620

Diasorin 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: Diasorin Inc. · 1951 Northwestern Ave S · Stillwater, MN · 55082-7536

Is this the product you have?

    • DiaSorin LIAISON HSV-2 Type Specific IgG
    • REF 310620
Lot codes and dates
  • UDI/DI 08056771600101
  • Lot Numbers
    • 136344
    • 136344A
    • 136344B
    • 136344C
    • 136520
    • 136520A
    • 136520B
    • 136520C
    • 136604
    • 136703
    • 136703A
    • 136703B
    • 136703C
    • 136775
Amount recalled
31992 units

Where it was sold

  • Nationwide

Why it was recalled

DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C 136775of LIAISON HSV-2 Type Specific IgG assay may produce increased equivocal and/or false positive results.

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

Data as of Sep 19, 6:56 PM UTC

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