QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL
Received Jun 24, 2024 · Event occurred May 7, 2024
Report 3004013603-2024-00003 · MDR key 19593618
Device
Generic name
Reagents, 2019-novel Coronavirus Nucleic Acid
Manufacturer
Qiagen GmbhCatalog number
691223
Lot number
178014042
Product problems
- Mechanical Problem
- Environmental Particulates
- No Apparent Adverse Event
- Mechanical Problem
- Environmental Particulates
- No Apparent Adverse Event
Patient
NA · Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO ADVERSE OUTCOMES WERE REPORTED. QIAGEN IS REPORTING THIS INCIDENT IN AN ABUNDANCE OF CAUTION AND IN ACCORDANCE WITH THE CONDITIONS OF APPROVAL UNDER THE EMERGENCY USE AUTHORIZATION FOR THIS PRODUCT.
Description of Event or Problem
DISCREPANT RESULTS FOR FLU A WITH QIASTAT-DX RESPIRATORY PANEL.
Additional Manufacturer Narrative
THE INVESTIGATION CONCLUDED THAT DUST/DIRT IN THE INSTRUMENT, POSSIBLY DUE TO CONSTRUCTION IN THE VICINITY, LED TO THE DISCREPANT RESULTS AND THAT THE KIT LOT IS NOT SUSPECT.