FDA recall Z-1702-2024

Alere San Diego, Inc. · Class II · device

Product

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

Worldwide distribution - US Nationwide and the countries of United Kingdom, Netherlands and Kenya.

Key facts

Status
Ongoing
Initiation date
2024-03-01
Report date
2024-05-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1702-2024