CLASS II ONGOING Device recall · Reported 8 May 2024 · FDA Enforcement Report
Abbott Cholestech LDX Battery Kit recalled by Alere San Diego
Alere San Diego is recalling Abbott Cholestech LDX Battery Kit, distributed nationwide in the US. The recall was initiated on 1 Mar 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1702-2024
- FDA event ID
- 94190
- Recalling firm
- Alere San Diego, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Mar 2024
- FDA classified
- 30 Apr 2024
- Reported
- 8 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- E. coli
- Device type
- Other Medical Devices
Timeline
| 1 Mar 2024 | Recall initiated by company | |
| 30 Apr 2024 | Classified by FDA | +60 days |
| 8 May 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Some strains of E. coli, such as O157:H7, produce a toxin that can cause severe stomach cramps, bloody diarrhea and, in a small number of cases, kidney failure.
Product as listed by the FDA
Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
Where it was distributed
Worldwide distribution - US Nationwide and the countries of United Kingdom, Netherlands and Kenya.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
All Lots/ UDI:
Where was it sold?
Worldwide distribution - US Nationwide and the countries of United Kingdom, Netherlands and Kenya.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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