Brand Name | AUTOSTAINER LINK 48 |
Type of Device | AUTOMATED SLIDE STAINER |
Manufacturer (Section D) |
AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. |
no.1 yishun avenue 7 |
singapore north east, 76892 3 |
SN 768923 |
|
Manufacturer (Section G) |
SHANDON DIAGNOSTICS LIMITED |
tudor road |
manor park |
runcorn, WA7 1 TA |
UK
WA7 1TA
|
|
Manufacturer Contact |
bryce
portier
|
1834 state highway 71 west |
cedar creek, TX 78612
|
4082185467
|
|
MDR Report Key | 13112622 |
MDR Text Key | 283316456 |
Report Number | 3003423869-2021-00312 |
Device Sequence Number | 1 |
Product Code |
KPA
|
UDI-Device Identifier | 05700572035497 |
UDI-Public | 05700572035497 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
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 |
Repair |
Type of Report
| Initial |
Report Date |
12/29/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/29/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | AS480 |
Device Catalogue Number | AS48030 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/01/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/01/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|