Brand Name | CF INPLEX ASR CARD |
Type of Device | ANALYTE SPECIFIC REAGENT |
Manufacturer (Section D) |
HOLOGIC, INC. |
10210 genetic center drive |
san diego CA 92121 |
|
Manufacturer (Section G) |
HOLOGIC, INC. |
10210 genetic center drive |
|
san diego CA 92121 |
|
Manufacturer Contact |
ron
domingo
|
10210 genetic center drive |
san diego, CA 92121
|
8584108167
|
|
MDR Report Key | 5556645 |
MDR Text Key | 42915949 |
Report Number | 2024800-2016-00010 |
Device Sequence Number | 1 |
Product Code |
MVU
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
04/07/2016 |
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 |
No Information
|
Device Expiration Date | 11/01/2016 |
Device Model Number | 95-0501 |
Device Catalogue Number | 95-0501 |
Device Lot Number | U35CH |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/14/2016
|
Initial Date FDA Received | 04/07/2016 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Life Threatening;
|
|
|