| Device Type ID | 3003 |
| Device Name | System, Test, Carcinoembryonic Antigen |
| Regulation Description | Tumor-associated Antigen Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.6010 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DHX |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3003 |
| Device | System, Test, Carcinoembryonic Antigen |
| Product Code | DHX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tumor-associated Antigen Immunological Test System. |
| CFR Regulation Number | 866.6010 [🔎] |
| Device Problems | |
|---|---|
Low Test Results | 24 |
Adverse Event Without Identified Device Or Use Problem | 15 |
High Test Results | 13 |
False Negative Result | 10 |
No Apparent Adverse Event | 8 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 7 |
Incorrect Or Inadequate Test Results | 4 |
Mechanical Problem | 4 |
Insufficient Information | 2 |
Tube | 2 |
Device Subassembly | 1 |
Filter | 1 |
Probe | 1 |
Device Ingredient Or Reagent | 1 |
Washer | 1 |
| Total Device Problems | 94 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beckman Coulter Inc. | II | Nov-06-2015 |
| 2 | Siemens Healthcare Diagnostics, Inc. | II | May-04-2018 |
| 3 | Tosoh Bioscience Inc | II | Jun-05-2018 |