Brand Name | ALINITY I AFP REAGENT KIT |
Type of Device | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Manufacturer (Section D) |
ABBOTT IRELAND |
finisklin business park |
sligo F91VY 44 |
EI F91VY44 |
|
MDR Report Key | 11778278 |
MDR Text Key | 252944109 |
Report Number | 3008344661-2021-00100 |
Device Sequence Number | 1 |
Product Code |
LOK
|
UDI-Device Identifier | 00380740130817 |
UDI-Public | 00380740130817 |
Combination Product (y/n) | N |
PMA/PMN Number | P120008 |
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 |
06/15/2021 |
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 | 12/13/2021 |
Device Model Number | 07P9020 |
Device Catalogue Number | 07P90-20 |
Device Lot Number | 23244FN00 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
04/30/2021
|
Initial Date FDA Received | 05/05/2021 |
Supplement Dates Manufacturer Received | 06/15/2021
|
Supplement Dates FDA Received | 06/15/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | ALNTY I PROCESSING MODU, 03R65-01, AI01400; ALNTY I PROCESSING MODU, 03R65-01, AI01400 |
|
|