Reported May 6, 2020 · Terminated

VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468

Ortho Clinical Diagnostics

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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 Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Lot codes and dates
  • UDI10758750005147
  • Lot Number2340
Amount recalled
3181

Where it was sold

  • Nationwide

Why it was recalled

The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 26, 2022 · Data as of Sep 19, 5:30 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.