Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
Summary
The FDA issued a Class II for Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 by Alere San Diego, Inc.. 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 .
Details
Source
Device Recall
External ID
Z-1702-2024
Action Date
2024-05-08
Status
Ongoing
Category
device
Product Description
Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
Lot/Code Info: All Lots/ UDI:
Quantity Affected: 559 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-01
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 175 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Alere San Diego, Inc. has 3 FDA actions in our database, including 2 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Alere San Diego, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Alere San Diego, Inc. have FDA actions?
Alere San Diego, Inc. has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1702-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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