Brand Name | CELL-DYN RUBY ANALYZER |
Type of Device | AUTOMATED HEMATOLOGY ANALYZER |
Manufacturer (Section D) |
ABBOTT DIAGNOSTICS DIVISION |
4551 great america parkway |
santa clara CA 95054 |
|
Manufacturer (Section G) |
ABBOTT DIAGNOSTICS DIVISION |
4551 great america parkway |
|
santa clara CA 95054 |
|
Manufacturer Contact |
noemi
romero-kondos, rn bsn
|
100 abbott park road |
dept. 09b9, lccp1-3 |
abbott park, IL 60064-3537
|
224667-512
|
|
MDR Report Key | 6428664 |
MDR Text Key | 70699074 |
Report Number | 2919069-2017-00060 |
Device Sequence Number | 1 |
Product Code |
GKZ
|
UDI-Device Identifier | 00380740017170 |
UDI-Public | (01)00380740017170 |
Combination Product (y/n) | N |
Reporter Country Code | RS |
PMA/PMN Number | K061667 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Other
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
03/23/2017 |
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 Catalogue Number | 08H67-01 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
03/10/2017 |
Initial Date FDA Received | 03/23/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Removal/Correction Number | 2919069-02/13/17-001-C |
Patient Sequence Number | 1 |
|
|