Brand Name | : ARCHITECT BNP CALIBRATORS |
Type of Device | BNP CALIBRATORS |
Manufacturer (Section D) |
ABBOTT LABORATORIES |
100 abbott park road |
abbott park IL 60064 3500 |
|
Manufacturer (Section G) |
ABBOTT LABORATORIES |
100 abbott park road |
|
abbott park IL 60064 3500 |
|
Manufacturer Contact |
christian
lee
|
100 abbott park road |
dept 09b9, bldg cp01-3 |
abbott park, IL 60064-3537
|
224668-294
|
|
MDR Report Key | 9296030 |
MDR Text Key | 220039522 |
Report Number | 1415939-2019-00218 |
Device Sequence Number | 1 |
Product Code |
JIT
|
UDI-Device Identifier | 00380740017460 |
UDI-Public | 00380740017460 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
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 |
11/08/2019 |
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 | 11/15/2019 |
Device Catalogue Number | 08K28-02 |
Device Lot Number | 44K82618 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/25/2019 |
Initial Date FDA Received | 11/08/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/15/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Removal/Correction Number | 3002809144-06/4/19-006R |
Patient Sequence Number | 1 |