Abbott Cholestech LDX Battery Kit Recall: Potential Swelling Risk
Abbott is recalling the Cholestech LDX Battery Kit due to a potential for battery swelling that could cause minor burns, cuts, abrasions, or electrical shock to users.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with potential for minor burns and electrical shock from battery swelling, but no reported illnesses or injuries. Per the rubric, theoretical hazards without reported harm in Class II recalls are scored at most 3.
Plain-English summary
Abbott, through its subsidiary Alere San Diego, Inc., is recalling the Cholestech LDX Battery Kit (Model: 3LP656194-PCM-LD, PN: 55170). This device is an external battery pack provided as an optional accessory to the Cholestech LDX Analyzer.
The battery kit has the potential to swell. This swelling could cause minor burns, cuts, abrasions, or low current electrical shock to users. The recall affects all lots and all UDI codes of this battery kit.
Approximately 559 units have been distributed worldwide, including in the United States, United Kingdom, Netherlands, and Kenya.
The recalled product
- Product
- Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
- Manufacturer
- Alere San Diego, Inc.
- Category
- Medical Device
- Affected units
- 559
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots/ UDI:
Distribution
Distributed nationwide across the United States.
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