MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-14 for GENETIC SYSTEMS HIV-1/HIV-2 PLUS O EIA 25256 manufactured by Bio-rad Laboratories.
| Report Number | 3022521-2019-00002 |
| MDR Report Key | 9187846 |
| Date Received | 2019-10-14 |
| Date of Report | 2019-10-14 |
| Date of Event | 2019-08-02 |
| Date Mfgr Received | 2019-09-27 |
| Device Manufacturer Date | 2019-01-30 |
| Date Added to Maude | 2019-10-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID BHEND |
| Manufacturer Street | 6565 185TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4254981758 |
| Manufacturer G1 | BIO-RAD LABORATORIES |
| Manufacturer Street | 6565 185TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GENETIC SYSTEMS HIV-1/HIV-2 PLUS O EIA |
| Generic Name | IVD, EIA |
| Product Code | MZF |
| Date Received | 2019-10-14 |
| Catalog Number | 25256 |
| Lot Number | 102PBB-50 |
| Device Expiration Date | 2019-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES |
| Manufacturer Address | 6565 185TH AVE NE REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-14 |