Brand Name | ARCHITECT HAVAB-IGG |
Type of Device | IGG ANTI-HAV |
Manufacturer (Section D) |
ABBOTT GERMANY |
max-planck-ring 2 |
wiesbaden 65205 |
GM 65205 |
|
MDR Report Key | 8388046 |
MDR Text Key | 137867790 |
Report Number | 3002809144-2019-00086 |
Device Sequence Number | 1 |
Product Code |
LOL
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Type of Report
| Initial,Followup |
Report Date |
05/30/2019 |
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 | 08/10/2019 |
Device Catalogue Number | 06C29-22 |
Device Lot Number | 92421LI00 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/12/2019 |
Initial Date FDA Received | 03/04/2019 |
Supplement Dates Manufacturer Received | 05/20/2019
|
Supplement Dates FDA Received | 05/30/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; SERIAL # (B)(4).; SERIAL # (B)(4). |
|
|