| Device Type ID | 3598 |
| Device Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Review Panel | Microbiology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | LOM |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3598 |
| Device | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Product Code | LOM |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 121 |
High Test Results | 50 |
False Positive Result | 36 |
Low Test Results | 36 |
False Negative Result | 32 |
Incorrect Or Inadequate Test Results | 25 |
No Apparent Adverse Event | 24 |
Mechanical Problem | 8 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Appropriate Term/Code Not Available | 1 |
Electrical /Electronic Property Problem | 1 |
Non Reproducible Results | 1 |
| Total Device Problems | 336 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ORTHO-CLINICAL DIAGNOSTICS | II | Jan-03-2019 |
| 2 | Siemens Healthcare Diagnostics, Inc | II | Oct-21-2014 |
| 3 | Siemens Healthcare Diagnostics, Inc. | II | May-04-2018 |