Reported Jan 26, 2022 · Ongoing

VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack

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

Is this the product you have?

  • VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Lot codes and dates
  • Lot # 2190
  • Product code(unique Device Identifier)8430373 (10758750004898)
Amount recalled
1416 units

Where it was sold

Why it was recalled

Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.

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, 6:55 PM UTC

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