FDA Adverse Event
Malfunction
Summary report: N
2250051-2006-00316
MDR report key: 741004
·
Received July 20, 2006
Report
- Report Number
- 2250051-2006-00316
- Event Type
- Malfunction
- Date Received
- July 20, 2006
- Product Code
- KSZ
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
ORTHO-CLINICAL DIAGNOSTICS QUALITY ASSURANCE PERFORMED RETAIN TESTING TO CONFIRM THE REACTIVITY OF THE E, FYE AND D ANTIGENS. SATISFACTORY RESULTS WERE OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KSZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |