Reported Aug 28, 2024 · Ongoing

Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD

Ventana Medical Systems, 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: Ventana Medical Systems, Inc. · 1910 E Innovation Park Dr · Oro Valley, AZ · 85755-1962

Is this the product you have?

  • Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody
  • REF790-4506, IVD
Lot codes and dates
  • UDI
    • 04015630972579/J04613
    • J11853
    • J17541
    • J25047
    • J30286
    • K00982
    • K06239
    • K09880
    • K14266
    • K19784
    • K26461
    • and M00669
Amount recalled
22,839 kits

Where it was sold

Why it was recalled

Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in 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, 3:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.