FDA Adverse Event
Malfunction
Summary report: N
1056600-2006-00530
MDR report key: 846589
·
Received December 5, 2006
Report
- Report Number
- 1056600-2006-00530
- Event Type
- Malfunction
- Date Received
- December 5, 2006
- Product Code
- KSZ
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
ORTHO-CLINICAL DIAGNOSTICS (OCD) PERFORMED RETAIN TESTING TO CONFIRM THE REACTIVITY OF THE JSA ANTIGEN. SATISFACTORY RESULTS WERE OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KSZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |