FDA Adverse Event
Injury
Summary report: N
QUEST INHIBITION ASSAY
MDR report key: 23818204
·
Received December 16, 2025
Report
- Report Number
- MW5180603
- Event Type
- Injury
- Date Received
- December 16, 2025
- Date of Event
- August 22, 2025
- Report Date
- December 8, 2025
- Manufacturer
- QUEST DIAGNOSTICS
- Product Code
- PGI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED ON 4/22/2026 FOR REPORT MW5180603 TO CHANGE THE PROCODE TO PGI.
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED ON 4/22/2026 FOR REPORT TO MW5180603 CHANGE THE PROCODE TO PGI.
Description of Event or Problem · 0
PATIENT HAD A FALSE POSITIVE HSV-2 TEST RESULT. PATIENT TESTED POSITIVE FOR HSV-2 ON A DIASORIN LIAISON XL HSV-2 IGG TEST AT QUEST DIAGNOSTICS. PATIENT ALSO TESTED POSITIVE ON QUEST INHIBITION ASSAY. PATIENT RECEIVED A CONFIRMATORY TEST VIA (B)(6) WHICH WAS NEGATIVE. PATIENT CODE: 4582. DEVICE CODE: 1227. PROCODE-JJX. REFERENCE REPORT: MW5180602.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2182200 | QUEST INHIBITION ASSAY | HERPES VIRUS (VZV, HSV1, HSV2), DNA DETECTION ASSAY FOR CUTANEOUS AND MUCOCUTANE | PGI | QUEST DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Male |