Brand Name | ARCHITECT FREE T4 REAGENT KIT |
Type of Device | RADIOIMMUNOASSAY, FREE THYROXINE |
Manufacturer (Section D) |
ABBOTT IRELAND DIAGNOSTICS DIVISION |
lisnamuck |
co. longford |
longford N39E9 32 |
EI N39E932 |
|
Manufacturer (Section G) |
ABBOTT IRELAND DIAGNOSTICS DIVISION |
lisnamuck |
co. longford |
longford N39E9 32 |
EI
N39E932
|
|
Manufacturer Contact |
nicole
jenne
|
max-planck-ring 2 |
post market surveillance |
wiesbaden 65205
|
GM
65205
|
6122582960
|
|
MDR Report Key | 19136185 |
MDR Text Key | 341015051 |
Report Number | 3005094123-2024-00187 |
Device Sequence Number | 1 |
Product Code |
CEC
|
UDI-Device Identifier | 380740119799 |
UDI-Public | (01)380740119799(17)240918(10)56026UD00 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K173122 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/18/2024 |
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 | 07K65-29 |
Device Lot Number | 56026UD00 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/26/2024
|
Initial Date FDA Received | 04/18/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 10/12/2023 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Treatment | ARC I2K PROC MOD, 03M74-01, (B)(6) |