Brand Name | IMMULITE/IMMULITE 1000 3RD GENERATION PSA |
Type of Device | IMMULITE/IMMULITE 1000 3RD GENERATION PSA |
Manufacturer (Section D) |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
registration #: 3002806944 |
glyn rhonwy |
llanberis, gwynedd, LL55 4EL |
UK LL55 4EL |
|
Manufacturer (Section G) |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
registration #: 3002806944 |
glyn rhonwy |
llanberis, gwynedd, LL55 4EL |
UK
LL55 4EL
|
|
Manufacturer Contact |
elizabeth
beato
|
511 benedict avenue |
tarrytown, NY 10591
|
9145243074
|
|
MDR Report Key | 6226324 |
MDR Text Key | 64019750 |
Report Number | 2432235-2017-00012 |
Device Sequence Number | 1 |
Product Code |
MTF
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P930027 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Health Professional
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
01/05/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/05/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | IMMULITE/IMMULITE 1000 3RD GENERATION PSA |
Device Catalogue Number | LK3PS1(D) |
Device Lot Number | D0120 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/14/2016 |
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 | 2432235-12/22/2016-003R |
Patient Sequence Number | 1 |