Brand Name | ARCHITECT ICT MODULE |
Type of Device | ICT MODULE |
Manufacturer (Section D) |
ABBOTT MANUFACTURING INC |
1921 hurd drive |
irving TX 75038 |
|
Manufacturer (Section G) |
ABBOTT MANUFACTURING INC |
1921 hurd drive |
|
irving TX 75038 |
|
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 | 7880346 |
MDR Text Key | 120384774 |
Report Number | 1628664-2018-01889 |
Device Sequence Number | 1 |
Product Code |
CGZ
|
UDI-Device Identifier | 00380740019327 |
UDI-Public | 00380740019327 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K980367 |
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 |
09/17/2018 |
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 Expiration Date | 12/26/2018 |
Device Catalogue Number | 09D28-03 |
Device Lot Number | 180326396 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/24/2018
|
Initial Date FDA Received | 09/17/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/26/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Removal/Correction Number | 1628664-08/29/18-003-R |
Patient Sequence Number | 1 |
Treatment | ARCHITECT C16000, LIST 03L77,; SERIAL (B)(4) |
|
|