InjuryLSL
APTIMA COMBO 2 ASSAY
Received Sep 25, 2019 · Event occurred Aug 26, 2019
Report 2024800-2019-00012 · MDR key 9121081
Device
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Not reported
- Unspecified Infection
- Unspecified Infection
Narrative
Description of Event or Problem
ON (B)(6) 2019, A CUSTOMER IN (B)(6) REPORTED RE-TESTING THEIR AC2 RESULTS IN ACCORDANCE WITH (B)(4). THEY FOUND ONE SAMPLE THAT GAVE AN AC2 RESULT OF 15 RLU WAS DETECTED AS ACT POSITIVE. SEQUENCING CONFIRMED A POINT MUTATION OF 23S, POSITION (B)(4).