Reported Jan 1, 2014 · Terminated

VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs

Ortho-Clinical Diagnostics

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: Ortho-Clinical Diagnostics · 100 Indigo Creek Dr · Rochester, NY · 14626-5101

Is this the product you have?

  • VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
Lot codes and dates
    • Product Code 1) 6801926
    • 2) 6801925
    • 3) 6802452
  • Lot numbers
    • 1) 6700
    • 2) 6731
    • 3) 6830
  • Expiry Dates
    • 1) 21 May 2013
    • 2) 24 July 2013
    • 3) 11 Sept 2013
Amount recalled
1,920 kits

Where it was sold

  • Nationwide

Why it was recalled

Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to 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

Notice updated May 18, 2018 · Data as of Sep 19, 5:29 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.