Reported Jun 2, 2021 · Terminated

Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d,…

Beckman Coulter 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: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232

Is this the product you have?

    • Access SARS-CoV-2 Antigen
    • REF C68668
  • UDI
    • (01)15099590742713
    • 3.30 mL/R1a
    • 4.70 mL/R1b
    • 4.20 mL/R1c
    • 3.10 mL
    • R1d
    • 3.10 mL
    • R1e
Lot codes and dates
  • All Lots
Amount recalled
1,034 units

Where it was sold

Why it was recalled

specimens collected in transport media may result is false negative results when stored in certain conditions.

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 19, 2023 · Data as of Sep 19, 5:39 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.