FDAFDA · Food and drugs·Recall number Z-1702-2024
Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
Published May 8, 2024 · Recall initiated: March 1, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Alere San Diego, Inc.
- Distributor
- Worldwide distribution - US Nationwide and the countries of United Kingdom, Netherlands and Kenya.
- Lot
- All Lots/ UDI:
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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