Lower riskMedical device recall · FDA · Published August 20, 2021
Microbiologics SARS-CoV-2 Swab Control Product Contaminated with Viral Sequences
Microbiologics recalls SARS-CoV-2 Process Control Swabs contaminated with plasmid DNA containing SARS-CoV-2 sequences. These swabs may cause false positive results in nucleic acid tests.
“Microbiologics SARS-CoV-2 Swab Control Product Contaminated with Viral Sequences.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61921-microbiologics-sars-cov-2-swab-control-product-contaminated-with-viral. Based on FDA recall #Z-2487-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2487-2021%22&limit=1).
The FDA announced on August 20, 2021, that Microbiologics Inc is recalling its SARS-CoV-2 Process Control (Swab) because the product is contaminated with plasmid DNA containing target SARS-CoV-2 sequences. The agency classified this as a Class II recall.
How to tell if you have it
Brand: Microbiologics
Product: SARS-CoV-2 Process Control (Swab)
Catalog #: HE0063S
Lot numbers: HE0063-100-1, HE0063-103-2, HE0063-103-3, HE0063-103-1, HE0063-104-1, HE0063-101-1 and HE0063-100-1
Units affected: 127
The hazard
According to the FDA, the SARS-CoV-2 Process Control (Swab) is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences. The product was intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect the virus.
Context
GovInfoNow's records show Microbiologics Inc has 35 other recalls on record since June 6, 2017. Recent Microbiologics recalls include a December 2, 2025 recall of KWIK-STIK 2-Pack units for potential failure to recover Campylobacter jejuni and a November 13, 2025 recall of Quality Control Kits due to lot labeling mix-ups. Other recent recalls of similar products include a March 16, 2026 Medline Blood Culture Kits recall for non-sterile alcohol prep pads risk and a June 11, 2026 Medline Neuro Pack Kits recall for contamination with Bacillus species.
How to tell if you have this one
Check for catalog number HE0063S and lot numbers HE0063-100-1, HE0063-103-2, HE0063-103-3, HE0063-103-1, HE0063-104-1, HE0063-101-1. These swabs are intended for use as external non-viable control materials in nucleic acid tests.
Brand
Microbiologics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Swab Lot Numbers
Identify if your swab has catalog number HE0063S and lot numbers listed above.
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-2487-2021 (August 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2487-2021 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.