The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2487-2021·Announced 2021-09-29

SARS-CoV-2 Process Control Swab Recalled Due to Plasmid DNA Contamination

Microbiologics Inc is recalling its SARS-CoV-2 Process Control (Swab) because certain lot numbers were contaminated with plasmid DNA containing SARS-CoV-2 sequences. The affected product was distributed in the United States and internationally.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II medical device recall with no reported illnesses or injuries. The contamination is a quality issue affecting laboratory testing control material, but poses no direct risk of patient harm.

Plain-English summary

Microbiologics Inc is recalling its SARS-CoV-2 Process Control (Swab) product. This item is intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus. A total of 127 units have been recalled.

The product was contaminated with plasmid DNA containing target SARS-CoV-2 sequences. This contamination was unintended and affects the accuracy and reliability of the product for its intended laboratory control purpose.

The affected product was distributed worldwide. Within the United States, it reached the following states: California, Florida, Georgia, Illinois, Maryland, Montana, Minnesota, North Carolina, New York, Nevada, Oregon, Tennessee, Texas, Utah, Washington, and Wisconsin. Internationally, affected lots were distributed to Austria, Canada, Colombia, France, Germany, Hong Kong, India, Ireland, Italy, Japan, and the United Kingdom.

The recalled lot numbers are HE0063-100-1, HE0063-103-2, HE0063-103-3, HE0063-103-1, HE0063-104-1, and HE0063-101-1. Laboratories that received this product should verify they do not have affected lots in use and should not use the recalled product for testing purposes. Users with questions should contact Microbiologics Inc.

The recalled product

Product
SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.
Manufacturer
Microbiologics Inc
Category
Medical Device — In Vitro Diagnostic / Process Control
Hazard
Affected units
127

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Catalog # HE0063S Lot #'s: HE0063-100-1
  • HE0063-103-2
  • HE0063-103-3
  • HE0063-103-1
  • HE0063-104-1
  • HE0063-101-1 and HE0063-100-1.

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

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