QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL
Received Dec 27, 2024 · Event occurred Nov 15, 2024
Report 3004013603-2024-00005 · MDR key 21029193
Device
Generic name
Reagents, 2019-novel Coronavirus Nucleic Acid
Manufacturer
Qiagen GmbhCatalog number
691214
Lot number
240113
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO INJURIES WERE REPORTED. QIAGEN IS REPORTING THE INCIDENT IN AN ABUNDANCE OF CAUTION AND IN ACCORDANCE WITH THE CONDITIONS OF AUTHORIZATION UNDER THE EMERGENCY USE AUTHORIZATION FOR THIS PRODUCT. THE QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL HEALTHCARE PROVIDER FACT SHEET PUBLISHED ALONGSIDE THE IFU STATES, LABORATORY TEST RESULTS SHOULD ALWAYS BE CONSIDERED IN THE CONTEXT OF CLINICAL OBSERVATIONS AND EPIDEMIOLOGICAL DATA IN MAKING A FINAL DIAGNOSIS AND PATIENT MANAGEMENT DECISIONS.
Description of Event or Problem
RESULTS FOR RHINOVIRUS WITH QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL WERE DISCREPANT WITH ANOTHER METHOD.