The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1210-2023·Announced 2023-03-15

Simplexa Flu A/B & RSV Diagnostic Kits Recalled for Leaking Components

DiaSorin is recalling 4,142 Simplexa Flu A/B & RSV Direct Gen II diagnostic kits due to leaking Direct amplification Discs that may cause contamination, cross-contamination, invalid test results, and system error codes.

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 recall with no reported illnesses or injuries. The product poses a risk of invalid diagnostic test results and contamination, but no actual patient harm has been documented, meeting criteria for High severity as a risk-of-harm product without reported injury.

Plain-English summary

DiaSorin Molecular LLC is recalling 4,142 units of Simplexa Flu A/B & RSV Direct Gen II (REF: MOL2655) including Reaction Mix (REF: MOL2656) with assay definition v5. The recall involves Direct amplification Discs that may leak during use, potentially causing contamination, cross-contamination between samples, invalid test results, and system error codes.

The affected products have been distributed nationwide across multiple states including New Jersey, Maine, North Dakota, Illinois, Michigan, Florida, Georgia, Arizona, Massachusetts, California, Missouri, South Dakota, Minnesota, Pennsylvania, Ohio, Vermont, Nebraska, Wisconsin, Colorado, Washington DC, Virginia, Texas, New Hampshire, Indiana, Iowa, Maryland, North Carolina, Alabama, New York, Kentucky, West Virginia, Rhode Island, Kansas, New Mexico, Oklahoma, Washington, South Carolina, Connecticut, Tennessee, Nevada, and Louisiana.

If you have received these kits, discontinue use and contact DiaSorin Molecular LLC or the FDA. Patients who received test results from affected kits should consult with their healthcare provider about the reliability of their test results. The specific lot numbers affected are: MOL2655/13648N with MOL2656/13649N, MOL2655/13882N with MOL2656/15164N, and MOL2655/15279N with MOL2656/15280N.

The recalled product

Product
Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.
Manufacturer
DiaSorin Molecular LLC
Category
Medical Device — In Vitro Diagnostic Assay
Hazard
Affected units
4,142

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 (2)

  • MOL2655/13882N/MOL2656/15164N
  • MOL2655/15279N/MOL2656/15280N

Distribution

Distributed nationwide across the United States.

The notice also names 41 states specifically:

Part of a larger recall action

This product is one of 2 recalled by DiaSorin Molecular LLC 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 2 products in this recall →

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