Class II

Medical Device Recall: Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170

Alere San Diego, Inc. · March 1, 2024

Reason for Recall

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.

Distribution

Worldwide distribution - US Nationwide and the countries of United Kingdom, Netherlands and Kenya.

States Affected

NATIONWIDE

Quantity Affected

559 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1702-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.