Reported May 18, 2022 · Ongoing

Accula SARS-CoV-2 Test, REF: COV4100

Mesa Biotech, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

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: MESA BIOTECH, INC · 6190 Cornerstone Ct E Ste 220 · San Diego, CA · 92121-4701

Is this the product you have?

  • Accula SARS-CoV-2 Test
  • REFCOV4100
Lot codes and dates
  • UDI/DI
    • B540COV41000
    • P22006-026
    • P22010-021
    • P22024-023
    • P22024-030
    • P22026-006
    • P22026-012
    • P22026-016
    • P22010-001
    • P22010-030
    • P22024-026
    • P22024-032
    • P22026-007
    • P22026-013
    • P22026-017
    • P22010-017
    • P22010-032
    • P22024-027
    • P22026-002
    • P22026-008
    • P22026-014
    • P22026-019
    • P22010-019
    • P22024-021
    • P22024-028
    • P22026-004
    • P22026-009
    • P22026-015
    • P22032-011
Amount recalled
6162

Where it was sold

Why it was recalled

Stop using this product now

SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.

Using this product could cause serious injury, illness or death — stop using it now.

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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, 6:18 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.