Z-1702-2024 Class II Ongoing
FDA device recall Z-1702-2024 was initiated by Alere San Diego, Inc. on Mar 1, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 559 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2024
- Initiation Date
- Mar 1, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 559 units
Product Description
Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
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 Pattern
Worldwide distribution - US Nationwide and the countries of United Kingdom, Netherlands and Kenya.
Code Information
All Lots/ UDI:
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1702-2024
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026