FDA Adverse Event
Malfunction
Summary report: N
1056600-2006-00501
MDR report key: 788465
·
Received November 21, 2006
Report
- Report Number
- 1056600-2006-00501
- Event Type
- Malfunction
- Date Received
- November 21, 2006
- Product Code
- KZS
- PMA / PMN Number
- 103778
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
ORTHO-CLINICAL DIAGNOSTICS (OCD) QUALITY ASSURANCE PERFORMED RETAIN TESTING TO CONFIRM THE REACTIVITY OF THE FYB 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 |