Alere San Diego, Inc. Recall 94190
Description: Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
Alere San Diego, Inc. Recall 94190 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1702-2024 |
| Event ID | 94190 |
| Event Description | Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of United Kingdom, Netherlands and Kenya. |
| Quantity | 559 units |
| Recall Reason | 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 which could cause minor burns, cuts or abrasions, or low current electrical shock to the user. |
| Device Classification | 20240508 |
| Device Code Info | All Lots/ UDI: |
| Center Classification Date | 20240430 |
| Recall Initiation Date | 20240301 |
| Recalling Firm | Alere San Diego, Inc. |
| Initial Notification | Letter |
| Similar To |