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.
What this means for you
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
- 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
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 →Related recalls
Same manufacturer · DiaSorin Molecular LLC
See all →- HighSimplexa Direct Amplification Disc Kit recalled for potential liquid spillage
FDA (Devices) · 2023-07-26
- HighCOVID-19 Diagnostic Test Kits May Leak, Causing Invalid Results
FDA (Devices) · 2023-03-15
- HighMedical Device Kit Poses Risk of Sample Leakage and Lab Contamination
FDA (Devices) · 2022-01-12
- HighCOVID-19 Diagnostic Control Pack Recalled for Unapproved Raw Materials
FDA (Devices) · 2021-10-27
- HighDiaSorin Simplexa VZV Swab Direct Recalled for Software Malfunction
FDA (Devices) · 2020-07-22
Same hazard · contamination
See all →- HighMedline Recalls Gynecologic Robotic Surgery Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls Surgical Convenience Kits Due to Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 419 Surgical Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
- HighMedline C-Section Convenience Kits Recalled for Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 71 Convenience Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02