Brand Name | FC 500 FLOW CYTOMETER |
Type of Device | COUNTER, DIFFERENTIAL CELL |
Manufacturer (Section D) |
BECKMAN COULTER |
250 s. kraemer blvd |
brea CA 92821 |
|
Manufacturer (Section G) |
BECKMAN COULTER |
11800 sw 147th avenue |
|
miami FL 33196 2031 |
|
Manufacturer Contact |
laurie
o'riordan
|
11800 sw 147th avenue |
miami, FL 33196-2031
|
3053802874
|
|
MDR Report Key | 9512929 |
MDR Text Key | 207556896 |
Report Number | 1061932-2019-01917 |
Device Sequence Number | 1 |
Product Code |
GKZ
|
UDI-Device Identifier | 15099590572822 |
UDI-Public | (01)15099590572822(11)NO-DATA |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K071681 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
12/23/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/23/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | TN,FC500 MPL FLOW CYTOMETER 100-240V,50/60HZ |
Device Catalogue Number | 626554 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 12/11/2019 |
Date Manufacturer Received | 12/11/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/01/2010 |
Is the Device Single Use? |
No
|
Type of Device Usage |
Unknown
|
Removal/Correction Number | 2050012-0108/2018-001C |
Patient Sequence Number | 1 |