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FDA (Device enforcement)Recalled 2024-03-01class ii

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

Hazard

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.

Details from the source

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. Quantity: 559 units Lot/code info: All Lots/ UDI:

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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