Device product
Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
Z-1702-2024
Product summary
- Event
- Event 94190
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 559 units
- Official record key
device-enforcement:Z-1702-2024
Official wording
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.
Code information: All Lots/ UDI:
Distribution pattern: Worldwide distribution - US Nationwide and the countries of United Kingdom, Netherlands and Kenya.
Derived failure modes
-
Unknown
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.