The Recall Desk
ModerateFDA (Devices)·Z-2486-2021·Announced 2021-09-29

Microbiologics SARS-CoV-2 Process Control Pellets Recalled for Product Specification Issue

Microbiologics Inc is recalling 218 units of SARS-CoV-2 process control pellets (catalog HE0062S) used to validate diagnostic tests. The FDA Class II recall involves product composition regarding RNA transcript content.

What this means for you

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: FDA Class II medical device recall with no reported illnesses or injuries. The recall involves a specification or composition discrepancy in a laboratory process control material not intended for patient use.

Plain-English summary

Microbiologics Inc is recalling SARS-CoV-2 Process Control (Pellet), catalog number HE0062S, in nine lot numbers (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). A total of 218 units are affected.

This product 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. The product contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets based on CDC and WHO consensus sequences.

The FDA has classified this as a Class II recall. The affected product was distributed worldwide, including in the United States (California, Florida, Georgia, Illinois, Maryland, Montana, Minnesota, North Carolina, New York, Nevada, Oregon, Tennessee, Texas, Utah, Washington, and Wisconsin) and internationally to Austria, Canada, Colombia, France, Germany, Hong Kong, India, Ireland, Italy, Japan, and the United Kingdom.

No illnesses or injuries have been reported in association with this product. Diagnostic laboratories in possession of affected materials should contact Microbiologics Inc for guidance on disposition.

The recalled product

Product
SARS-CoV-2 Process Control (Pellet) - 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 — Diagnostic Control
Hazard
  • specification-discrepancy

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 (8)

  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category