FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 1113623
·
Received June 10, 2008
Report
- Report Number
- 2250051-2008-00266
- Event Type
- Malfunction
- Date Received
- June 10, 2008
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Product Code
- KSZ
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
ORTHO-CLINICAL DIAGNOSTICS (OCD) QA PERFORMED RETAINED TESTING TO CONFRIM THE REACTIVITY OF THE JKB ANTIGEN. RESULTS WERE SATISFACTORY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | KSZ | ORTHO-CLINICAL DIAGNOSTICS, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |