Brand Name | ACCESS 2 IMMUNOASSAY SYSTEM |
Type of Device | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
Baseline Brand Name | ACCESS 2 IMMUNOASSAY SYSTEM |
Baseline Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
Baseline Catalogue Number | 81600N |
Baseline Model Number | ACCESS 2 IMMUNOSSAY SYSTEM |
Baseline Device 510(K) Number | |
Baseline Device PMA Number | |
Manufacturer (Section F) |
BECKMAN COULTER, INC. |
1000 lake hazeltine drive |
chaska MN 55318 |
|
Manufacturer (Section D) |
BECKMAN COULTER, INC. |
1000 lake hazeltine drive |
chaska MN 55318 |
|
Manufacturer Contact |
anne
saber, director
|
11800 sw 147th avenue |
mail stop: 32-c206 |
miami
, FL 33116-9015 |
(305)
380
-2618
|
|
Device Event Key | 456974 |
MDR Report Key | 468048 |
Event Key | 443585 |
Report Number | 2122870-2003-00054 |
Device Sequence Number | 1 |
Product Code | JJE |
Report Source |
Manufacturer
|
Source Type |
Health Professional
|
Reporter Occupation |
UNKNOWN
|
Remedial Action |
Replace,Inspection
|
Type of Report
| Initial |
Report Date |
05/19/2003 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 06/19/2003 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
Invalid Data
|
Device MODEL Number | ACCESS 2 IMMUNOSSAY SYSTEM |
Device Catalogue Number | 81600N |
Was Device Available For Evaluation? |
No Answer Provided
|
Is The Reporter A Health Professional? |
No Answer Provided
|
Was the Report Sent to FDA? |
No
|
Was Device Evaluated By Manufacturer? |
No
|
Date Device Manufactured | 08/01/2002 |
Is The Device Single Use? |
No
|
Is the Device an Implant? |
No
|
Is this an Explanted Device? |
|
Type of Device Usage |
Invalid Data
|