Brand Name | IMMULITE/IMMULITE 1000 BR-MA |
Type of Device | IMMULITE/IMMULITE 1000 BR-MA |
Manufacturer (Section D) |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
glyn rhonwy |
llanberis, caernarfon, gwynedd LL55 4EL |
UK LL55 4EL |
|
Manufacturer (Section G) |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
uk registration #: 3002806944 |
glyn rhonwy |
llanberis, caernarfon, gwynedd LL55 4EL |
UK
LL55 4EL
|
|
Manufacturer Contact |
aarti
aziz
|
511 benedict avenue |
tarrytown, NY 10591
|
9145242683
|
|
MDR Report Key | 7041476 |
MDR Text Key | 93070783 |
Report Number | 2432235-2017-00617 |
Device Sequence Number | 1 |
Product Code |
MOI
|
UDI-Device Identifier | 00630414963655 |
UDI-Public | 00630414963655 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K013984 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,study |
Reporter Occupation |
Other
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup,Followup |
Report Date |
12/19/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/17/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | IMMULITE/IMMULITE 1000 BR-MA |
Device Catalogue Number | LKBR1 |
Device Lot Number | 313 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 12/18/2017 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | 2432235-12/19/2017-004-C |
Patient Sequence Number | 1 |
|
|