FDA Adverse Event
Malfunction
Summary report: N
SERACLONE ANTI-N (MNS2)
MDR report key: 2513167
·
Received February 9, 2011
Report
- Report Number
- 9610824-2011-00265
- Event Type
- Malfunction
- Date Received
- February 9, 2011
- Date of Event
- December 8, 2010
- Report Date
- February 9, 2011
- Manufacturer
- BIO-RAD MEDICAL DIAGNOSTICS GMBH
- Product Code
- KSZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED WEAKLY FALSE POSITIVE REACTIONS OF N NEGATIVE CELLS FROM THEIR CELL PANEL OF A COMPETITOR WITH SERACLONE ANTI-N ART. -NO. (B)(4), LOT 1934140. THE CUSTOMER USES THE CELL PANEL AS CONTROL CELLS. THE CUSTOMER HAS SENT US VIALS OF THE COMPLAINED LOT OF REAGENT AND THE AFFECTED CELL PANEL OF THE COMPETITOR. THE TESTING OF THE QUALITY CONTROL LABORATORY CONFIRMED THE FALSE POSITIVE REACTIONS OF CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERACLONE ANTI-N (MNS2) | SERACLONE ANTI-N | KSZ | BIO-RAD MEDICAL DIAGNOSTICS GMBH | 1934140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |