FDA Enforcement
Class II
Ongoing
Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
Recall: Z-1702-2024
·
Reported May 8, 2024
Enforcement
- Recall Number
- Z-1702-2024
- Event ID
- 94190
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Alere San Diego, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 8, 2024
- Initiation Date
- March 1, 2024
- Classification Date
- April 30, 2024
- Address
- 9975 Summers Ridge Rd, San Diego, CA, 92121-2997, United States
Description
Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
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 Info
All Lots/ UDI:
Distribution
Worldwide distribution - US Nationwide and the countries of United Kingdom, Netherlands and Kenya.
Quantity
559 units