Brand Name | FC 500 FLOW CYTOMETER |
Type of Device | COUNTER, DIFFERENTIAL CELL |
Manufacturer (Section D) |
BECKMAN COULTER |
250 s. kraemer blvd |
brea FL 92821 |
|
Manufacturer (Section G) |
BECKMAN COULTER |
11800 sw 147th avenue |
|
miami FL 33196 2031 |
|
Manufacturer Contact |
harry
long
|
1000 lake hazeltine drive |
m/s r590c |
chaska, MN 55318
|
9523681224
|
|
MDR Report Key | 11077527 |
MDR Text Key | 223779115 |
Report Number | 1061932-2020-00184 |
Device Sequence Number | 1 |
Product Code |
GKZ
|
UDI-Device Identifier | 15099590572839 |
UDI-Public | (01)15099590572839(11)NO-DATA |
Combination Product (y/n) | N |
Reporter Country Code | FR |
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 |
12/28/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | TN, FC500 FLOW CYTOMETER 100-240V, 50/60HZ |
Device Catalogue Number | 626553 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/16/2020 |
Initial Date FDA Received | 12/28/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Removal/Correction Number | 2050012-0108/2018-001C |
Patient Sequence Number | 1 |