Brand Name | CELL-DYN EMERALD 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 | 8705029 |
MDR Text Key | 151146926 |
Report Number | 2919069-2019-00072 |
Device Sequence Number | 1 |
Product Code |
GKZ
|
UDI-Device Identifier | 00380740020088 |
UDI-Public | 00380740020088 |
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | K081495 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
06/17/2019 |
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 | 09H39-01 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/13/2019 |
Initial Date FDA Received | 06/17/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/01/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Removal/Correction Number | 2919069-05/09/19-002-R |
Patient Sequence Number | 1 |