Brand Name | ARCHITECT HAVAB-G REAGENT KIT |
Type of Device | HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY) |
Manufacturer (Section D) |
ABBOTT GMBH |
max-planck-ring 2 |
wiesbaden 65205 |
GM 65205 |
|
MDR Report Key | 11499912 |
MDR Text Key | 266846530 |
Report Number | 3002809144-2021-00171 |
Device Sequence Number | 1 |
Product Code |
LOL
|
Combination Product (y/n) | N |
PMA/PMN Number | N/A |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Type of Report
| Initial,Followup,Followup |
Report Date |
06/23/2021 |
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 | 09/24/2021 |
Device Catalogue Number | 06C29-27 |
Device Lot Number | 20601BE00 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/18/2021 |
Initial Date FDA Received | 03/16/2021 |
Supplement Dates Manufacturer Received | 04/16/2021 06/23/2021
|
Supplement Dates FDA Received | 05/10/2021 06/23/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | ARC I1000SR MOD, 01L86-01, I1SR56731; ARC I1000SR MOD, 01L86-01, I1SR56731; ARC I1000SR MOD, 01L86-01, I1SR56731 |
|
|