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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Alere San Diego, Inc.: Cholestech LDX Battery Kits Recalled Due to Swelling and Burn Risks

Agency Publication Date: April 30, 2024
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Summary

Alere San Diego is recalling 559 Abbott Cholestech LDX Battery Kits (Model 3LP656194-PCM-LD, PN: 55170). These external battery packs, used as an optional accessory for the Cholestech LDX Analyzer, have the potential to swell during use. This defect can lead to minor burns, cuts, abrasions, or a low-current electrical shock to the user. These units were distributed nationwide in the United States and internationally.

Risk

The battery pack may physically swell or expand, which can cause the casing to crack or overheat, leading to direct skin burns, lacerations from damaged housing, or exposure to electrical current.

What You Should Do

  1. Identify if you have the affected accessory by checking for the Abbott Cholestech LDX Battery Kit, Model number 3LP656194-PCM-LD and Part Number (PN) 55170.
  2. Carefully inspect the external battery pack for any signs of swelling, bulging, or damage to the outer casing.
  3. Contact your healthcare provider or Alere San Diego (now part of Abbott) immediately to report affected units and to receive instructions on how to safely handle or return the battery pack.
  4. If you experience any issues with the device, you should contact the manufacturer directly at their San Diego facility located at 9975 Summers Ridge Rd, San Diego, CA 92121.
  5. For additional information or to report a related safety issue, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

manufacturer or healthcare provider Consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Abbott Cholestech LDX Battery Kit
Model / REF:
3LP656194-PCM-LD
PN: 55170
Lot Numbers:
All Lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94190
Status: Active
Manufacturer: Alere San Diego, Inc.
Sold By: Authorized distributors
Manufactured In: United States
Units Affected: 559 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.