The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0699-2022·Announced 2022-03-09

Helix Elite Molecular Reference Standard Recall for Failed Shelf-Life Testing

Microbiologics Inc is recalling Helix Elite Molecular Standards for inactivated RSV A because real-time shelf life testing failed at 24 months, indicating the product may not maintain stability through its claimed expiration date.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with demonstrated stability failure affecting diagnostic accuracy. While no illnesses or injuries have been reported, failed shelf-life testing represents a risk-of-harm product: unreliable molecular reference standards could compromise diagnostic test accuracy and reliability.

Plain-English summary

Microbiologics Inc is recalling Helix Elite Molecular Standards: Inactivated Respiratory Syncytial Virus A Strain Long, a lyophilized molecular reference standard used for quality control and diagnostic testing. The product consists of lyophilized pellets packaged in individual single-use vials.

The recall is due to failed real-time shelf life testing at 24 months. The product is labeled as stable at 2°C–25°C through its expiration date; however, real-time testing revealed stability failure at the 24-month testing point, indicating the product may not maintain its claimed potency and stability characteristics through the expiration date.

The affected lot (HE0028N-102-1, Catalog Number HE0028N) has been distributed worldwide, including throughout the United States in Alaska, California, District of Columbia, Florida, Iowa, Idaho, Kansas, Louisiana, Maryland, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington, and West Virginia, as well as internationally to Australia, Belgium, Canada, India, and the United Kingdom.

Laboratories and testing facilities using this product should verify the viability of affected lots and consider discontinuing use pending further guidance from Microbiologics Inc, as unreliable reference standards could compromise the accuracy of molecular diagnostic testing.

The recalled product

Product
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2¿C-25¿C through the expiration date. Each lyophilized pellet is packaged in a…
Manufacturer
Microbiologics Inc
Category
Medical Device — Diagnostic Reference Standard
Hazard
Affected units
1

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 (3)

  • Catalog Number: HE0028N
  • Lot Number: HE0028N-102-1
  • UDI: 10845357042023

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Microbiologics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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