San Diego, CA, US · 1 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | Class II | Clinical Chemistry | 1 | 2023-09-20 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-03-01 | Class II | Ongoing | Z-1702-2024 | Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 | — | There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell whic… |
| 2022-06-24 | Class II | Ongoing | Z-1508-2022 | The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL c… | — | Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bilirubin, a… |