UnratedMedical device recall · FDA · Published August 20, 2021
Microbiologics SARS-CoV-2 Process Control Pellet Recall: RNA Targets Risk
Microbiologics recalls SARS-CoV-2 Process Control Pellets with CDC/WHO RNA targets for nucleic acid tests. Recalled lots may pose risks if used incorrectly in testing.
The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).
Take action
Contact the company
📍Recalling firmMicrobiologics Inc200 Cooper Ave N · Saint Cloud, MN 56303-4440
“Microbiologics SARS-CoV-2 Process Control Pellet Recall: RNA Targets Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61917-microbiologics-sars-cov-2-process-control-pellet-recall-rna-targets. Based on FDA recall #Z-2486-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2486-2021%22&limit=1).
The FDA announced on August 20, 2021, that Microbiologics Inc is recalling its SARS-CoV-2 Process Control (Pellet) because it contains RNA transcripts with diagnostically relevant SARS-CoV-2 targets. The agency classified the recall as Class II.
How to tell if you have it
Brand: Microbiologics
Product: SARS-CoV-2 Process Control (Pellet)
Catalog #: HE0062S
Lot codes: 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
Units affected: 218
The hazard
According to the FDA, the SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets. The product is intended for use as an external, non-viable control material to evaluate nucleic acid tests detecting the virus.
Context
GovInfoNow's records show Microbiologics Inc has 35 other recalls on record since June 6, 2017. Other recent recalls of similar products include Microbiologics KWIK-STIK 2-Pack (December 2, 2025), Microbiologics KWIK-STIK Quality Control Kit Recall (November 13, 2025), and Microbiologics LYFO-DISK Recall (June 27, 2025).
How to tell if you have this one
Check for catalog number HE0062S and lots HE0062-01-1 through HE0062-06-2. These pellets were sold for use in nucleic acid tests to evaluate SARS-CoV-2 detection.
Brand
Microbiologics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the catalog number and lot numbers listed in the recall notice to confirm if your product is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 16 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of CA, FL, GA, IL, MD, MT, MN, NC, NY, NV, OR, TN, TX,UT, WA and WI. The countries of Austria, Canada, Colombia, France, Germany, Hong Kong, India, Ireland, Italy, Japan and…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Georgia, Illinois, Maryland, Minnesota, Montana, Nevada, New York, North Carolina, Oregon, Tennessee, Texas, Utah, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2486-2021 (August 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2486-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.