The Recall Desk
HighFDA (Devices)·Z-1702-2024·Announced 2024-05-08

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.

What this means for you

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
Hazard
  • battery-swelling
  • burn-injury
  • electrical-shock
  • cut-abrasion

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.

Related recalls

Same category