FDA Adverse Event
Other
Summary report: N
TOSOH AIA 600II AND REAGENTS
MDR report key: 2627800
·
Received October 15, 2009
Report
- Report Number
- 3004529019-2009-00005
- Event Type
- Other
- Date Received
- October 15, 2009
- Date of Event
- June 17, 2009
- Report Date
- July 15, 2009
- Manufacturer
- TOSOH HITEC INC.
- Product Code
- KHO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
UNAUTHORIZED OFFERING FOR SALE OF REFURBISHED TOSOH BIOSCIENCE INC. (TBI) INSTRUMENTS AND REAGENTS. PROVISION OF DOCUMENTATION TO A PROSPECTIVE CUSTOMER MAKING FALSE PRODUCT CLAIMS. WILLFULLY OBSCURING THE HANDLING AND STORAGE CONDITIONS AS WELL AS OBSTRUCTING TBI¿S RECALL PROTOCOL THROUGH THESE ACTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOSOH AIA 600II AND REAGENTS | AUTOMATED IMMUNOASSAY ANALYZER | KHO | TOSOH HITEC INC. | 600II |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |