Reported Sep 29, 2021 · Terminated

SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to…

Microbiologics 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: Microbiologics Inc · 200 Cooper Ave N · Saint Cloud, MN · 56303-4440

Is this the product you have?

  • SARS-CoV-2 Process
  • Control (Pellet) - Product Usageintended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus
Lot codes and dates
    • Catalog # HE0062S Lot #'s: HE0062-01-1
    • HE0062-01-2
    • HE0062-03-1
    • HE0062-04-1
    • HE0062-04-2
    • HE0062-05-1
    • HE0062-05-2
    • HE0062-06-1 and HE0062-06-2
Amount recalled
218

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).

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 Jan 12, 2023 · Data as of Sep 19, 7:39 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.