Medical device recalls Moderate risk

Alere San Diego, Inc. recalls Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170

Recall date
March 1, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1702-2024
FDA classification
Class II
Brand / firm
Alere San Diego, Inc.
Sold / distributed
Worldwide distribution - US Nationwide and the countries of United Kingdom, Netherlands and Kenya.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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