Brand Name | IMMULITE/IMMULITE 1000 CORTISOL |
Type of Device | IMMULITE/IMMULITE 1000 CORTISOL |
Manufacturer (Section D) |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED |
glyn rhonwy |
llanberis caernarfon, gwynedd, wales LL55 4EL |
UK LL55 4EL |
|
Manufacturer (Section G) |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED |
registration #3002806944 |
glyn rhonwy |
llanberis, caernarfon, gwynedd, wales LL55 4EL |
UK
LL55 4EL
|
|
Manufacturer Contact |
elizabeth
beato
|
511 benedict avenue |
tarrytown, NY 10591
|
9145243074
|
|
MDR Report Key | 4111338 |
MDR Text Key | 4940443 |
Report Number | 2432235-2014-00550 |
Device Sequence Number | 1 |
Product Code |
CGR
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K931409 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Health Professional
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
09/12/2014 |
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 |
Other Health Care Professional
|
Device Model Number | IMMULITE/IMMULITE 1000 CORTISOL |
Device Catalogue Number | LKCO |
Device Lot Number | 382 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/12/2014
|
Initial Date FDA Received | 09/23/2014 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | 2432235-09/22/14-003R |
Patient Sequence Number | 1 |