Reported Jan 29, 2014 · Terminated

VITROS Chemistry Products COCM Reagent

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 Chemistry Products COCM Reagent
Lot codes and dates
  • Product Code6801995
  • Lot numbers1) 1525-09-2754
  • Exp Date
    • 1 Nov 2013
    • 2) 1525-10-2091
  • Exp Date
    • 1 March 2014
    • 3) 1525-10-3062
  • Exp Date1 April 2014
Amount recalled
3,342 units

Where it was sold

Why it was recalled

Inaccurate quality control 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 17, 2018 · Data as of Sep 19, 5:26 PM UTC

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