Solana SARS-CoV-2 Assay CoronavirusRecalls & reported problems

Diagnostic Hybrids, Inc. · Solana SARS-CoV-2 Assay · Class N

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Diagnostic Hybrids Solana SARS-CoV-2 test is a reagent used to detect the coronavirus. Its 328 reports describe false positive results, false negative results, and erratic readings. The reports include no deaths and no injuries. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 328
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 328 adverse event reports that list this exact device (DI 30014613339656), received between Apr 20, 2021 and Aug 15, 2022 — classified as 328 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (244 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

No Apparent Adverse Event322
False Positive Result244
False Negative Result43
Imprecise or Erratic Results32
Incorrect, Inadequate or Imprecise Result or Readings1

Patient problems

No Clinical Signs, Symptoms or Conditions325
Insufficient Information7

Recent adverse event reports

The 25 most recent of 328 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 15, 2022False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event
REPORTED FALSE NEGATIVE SARS RESULT. THE CUSTOMER COMMUNICATED THE RESULT WAS POSITIVE BY ANOTHER MOLECULAR METHOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15227085 ↗
MalfunctionAug 15, 2022False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event
REPORTED FALSE NEGATIVE SARS RESULT. THE CUSTOMER COMMUNICATED THE RESULT WAS POSITIVE BY ANOTHER MOLECULAR METHOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15227016 ↗
MalfunctionJul 22, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT. CUSTOMER COMMUNICATED THE ISSUE IS OCCURRING OVER SEVERAL INSTRUMENTS AND WITH NEGATIVE CONTROLS (EACH PATIENT EVENT WILL BE FILED SEPARATELY). SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN AND NO CONFIRMATION TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090069 ↗
MalfunctionJul 22, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT. CUSTOMER COMMUNICATED THE ISSUE IS OCCURRING OVER SEVERAL INSTRUMENTS AND WITH NEGATIVE CONTROLS (EACH PATIENT EVENT WILL BE FILED SEPARATELY). SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN AND NO CONFIRMATION TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090067 ↗
MalfunctionJul 22, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT. CUSTOMER COMMUNICATED THE ISSUE IS OCCURRING OVER SEVERAL INSTRUMENTS AND WITH NEGATIVE CONTROLS (EACH PATIENT EVENT WILL BE FILED SEPARATELY). SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN AND NO CONFIRMATION TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090066 ↗
MalfunctionJul 22, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT. CUSTOMER COMMUNICATED THE ISSUE IS OCCURRING OVER SEVERAL INSTRUMENTS AND WITH NEGATIVE CONTROLS (EACH PATIENT EVENT WILL BE FILED SEPARATELY). SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN AND NO CONFIRMATION TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090065 ↗
MalfunctionJul 22, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT. CUSTOMER COMMUNICATED THE ISSUE IS OCCURRING OVER SEVERAL INSTRUMENTS AND WITH NEGATIVE CONTROLS (EACH PATIENT EVENT WILL BE FILED SEPARATELY). SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN AND NO CONFIRMATION TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090064 ↗
MalfunctionJul 22, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT. CUSTOMER COMMUNICATED THE ISSUE IS OCCURRING OVER SEVERAL INSTRUMENTS AND WITH NEGATIVE CONTROLS (EACH PATIENT EVENT WILL BE FILED SEPARATELY). SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN AND NO CONFIRMATION TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090063 ↗
MalfunctionJul 22, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT. CUSTOMER COMMUNICATED THE ISSUE IS OCCURRING OVER SEVERAL INSTRUMENTS AND WITH NEGATIVE CONTROLS (EACH PATIENT EVENT WILL BE FILED SEPARATELY). SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN AND NO CONFIRMATION TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090062 ↗
MalfunctionJul 22, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT. CUSTOMER COMMUNICATED THE ISSUE IS OCCURRING OVER SEVERAL INSTRUMENTS AND WITH NEGATIVE CONTROLS (EACH PATIENT EVENT WILL BE FILED SEPARATELY). SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN AND NO CONFIRMATION TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090061 ↗
MalfunctionJul 22, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT. CUSTOMER COMMUNICATED THE ISSUE IS OCCURRING OVER SEVERAL INSTRUMENTS AND WITH NEGATIVE CONTROLS (EACH PATIENT EVENT WILL BE FILED SEPARATELY). SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN AND NO CONFIRMATION TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090060 ↗
MalfunctionJul 22, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT. CUSTOMER COMMUNICATED THE ISSUE IS OCCURRING OVER SEVERAL INSTRUMENTS AND WITH NEGATIVE CONTROLS (EACH PATIENT EVENT WILL BE FILED SEPARATELY). SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN AND NO CONFIRMATION TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090058 ↗
MalfunctionJul 22, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT. CUSTOMER COMMUNICATED THE ISSUE IS OCCURRING OVER SEVERAL INSTRUMENTS AND WITH NEGATIVE CONTROLS (EACH PATIENT EVENT WILL BE FILED SEPARATELY). SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN AND NO CONFIRMATION TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090057 ↗
MalfunctionJul 22, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT. CUSTOMER COMMUNICATED THE ISSUE IS OCCURRING OVER SEVERAL INSTRUMENTS AND WITH NEGATIVE CONTROLS (EACH PATIENT EVENT WILL BE FILED SEPARATELY). SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN AND NO CONFIRMATION TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090028 ↗
MalfunctionJul 22, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT. CUSTOMER COMMUNICATED THE ISSUE IS OCCURRING OVER SEVERAL INSTRUMENTS AND WITH NEGATIVE CONTROLS (EACH PATIENT EVENT WILL BE FILED SEPARATELY). SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN AND NO CONFIRMATION TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090026 ↗
MalfunctionJul 22, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT. CUSTOMER COMMUNICATED THE ISSUE IS OCCURRING OVER SEVERAL INSTRUMENTS AND WITH NEGATIVE CONTROLS (EACH PATIENT EVENT WILL BE FILED SEPARATELY). SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN AND NO CONFIRMATION TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090024 ↗
MalfunctionJul 22, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT. CUSTOMER COMMUNICATED THE ISSUE IS OCCURRING OVER SEVERAL INSTRUMENTS AND WITH NEGATIVE CONTROLS (EACH PATIENT EVENT WILL BE FILED SEPARATELY). SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN AND NO CONFIRMATION TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090022 ↗
MalfunctionJul 22, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT. CUSTOMER COMMUNICATED THE ISSUE IS OCCURRING OVER SEVERAL INSTRUMENTS AND WITH NEGATIVE CONTROLS (EACH PATIENT EVENT WILL BE FILED SEPARATELY). SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN AND NO CONFIRMATION TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090021 ↗
MalfunctionJul 22, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT. CUSTOMER COMMUNICATED THE ISSUE IS OCCURRING OVER SEVERAL INSTRUMENTS AND WITH NEGATIVE CONTROLS (EACH PATIENT EVENT WILL BE FILED SEPARATELY). SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN AND NO CONFIRMATION TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090020 ↗
MalfunctionJul 22, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT. CUSTOMER COMMUNICATED THE ISSUE IS OCCURRING OVER SEVERAL INSTRUMENTS AND WITH NEGATIVE CONTROLS (EACH PATIENT EVENT WILL BE FILED SEPARATELY). SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN AND NO CONFIRMATION TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090010 ↗
MalfunctionJul 22, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT. CUSTOMER COMMUNICATED THE ISSUE IS OCCURRING OVER SEVERAL INSTRUMENTS AND WITH NEGATIVE CONTROLS (EACH PATIENT EVENT WILL BE FILED SEPARATELY). SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN AND NO CONFIRMATION TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090009 ↗
MalfunctionJul 22, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT. CUSTOMER COMMUNICATED THE ISSUE IS OCCURRING OVER SEVERAL INSTRUMENTS AND WITH NEGATIVE CONTROLS (EACH PATIENT EVENT WILL BE FILED SEPARATELY). SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN AND NO CONFIRMATION TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090007 ↗
MalfunctionJul 22, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT. CUSTOMER COMMUNICATED THE ISSUE IS OCCURRING OVER SEVERAL INSTRUMENTS AND WITH NEGATIVE CONTROLS (EACH PATIENT EVENT WILL BE FILED SEPARATELY). SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN AND NO CONFIRMATION TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090006 ↗
MalfunctionJul 22, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
CUSTOMER REPORTING SUSPECTED FALSE POSITIVE SARS RESULT. CUSTOMER COMMUNICATED THE ISSUE IS OCCURRING OVER SEVERAL INSTRUMENTS AND WITH NEGATIVE CONTROLS (EACH PATIENT EVENT WILL BE FILED SEPARATELY). SYMPTOMATIC STATUS OF PATIENT IS UNKNOWN AND NO CONFIRMATION TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15090001 ↗
MalfunctionJun 30, 2022False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event
REPORTED FALSE POSITIVE SARS RESULT FOR 1 PATIENT. IT IS UNKNOWN IF THE PATIENT WAS SYMPTOMATIC. THE CUSTOMER COMMUNICATED THE PATIENT LATER TESTED NEGATIVE WITH MOLECULAR (PCR TESTING) METHOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14876136 ↗

Device details

UDI-DI	`30014613339656`
Brand	Solana SARS-CoV-2 Assay
Model	Coronavirus
Catalog no.	M313
Company	Diagnostic Hybrids, Inc.
Product code	QJR · Reagents, 2019-novel coronavirus nucleic acid
Class	Class N
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 25, 2021

Device type (GMDN): SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a nucleic acid technique (NAT). This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page