FDA Adverse Event
Malfunction
Summary report: N
1056600-2006-00483
MDR report key: 965127
·
Received November 8, 2006
Report
- Report Number
- 1056600-2006-00483
- Event Type
- Malfunction
- Date Received
- November 8, 2006
- Product Code
- KZS
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
ORTHO-CLINICAL DIAGNOSTICS (OCD) QA PERFORMED RETAIN TESTING TO CONFIRM THE REACTIVITY OF THE E ANTIGENS. SATISFACTORY RESULTS WERE OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KZS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |