FDA Adverse Event
Malfunction
Summary report: N
BIO-TEK AUTOMATED MICROPLATE READER
MDR report key: 581946
·
Received February 28, 2005
Report
- Report Number
- 1823260-2005-00289
- Event Type
- Malfunction
- Date Received
- February 28, 2005
- Date of Event
- January 27, 2005
- Report Date
- February 17, 2005
- Manufacturer
- BIO-TEK INSTRUMENTS, INC.
- Product Code
- JJQ
- Removal / Correction Number
- 1823260-01/27/05-001-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING AN INTERNAL REVIEW, IT WAS DETERMINED THAT THE PRE-PROGRAMMED PARAMETERS FOR THE BIO-TEK AUTOMATED MICROPLATE READER CONTAINS INCORRECT PARAMETERS FOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.0
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIO-TEK AUTOMATED MICROPLATE READER | GENERAL PURPOSE INSRUMENT | JJQ | BIO-TEK INSTRUMENTS, INC. | ELX 808 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |