Severity
Moderate
FDA Devices recall · Reported May 8, 2024
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…
Alere San Diego, Inc. recalled Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 - a moderate-severity action.
Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 was recalled by Alere San Diego, Inc. in May 8, 2024. Reason: There is a potential that the Cholestech LDX battery (an external battery pack available as an optional acces…. Check the official notice for the remedy. Verify recall #Z-1702-2024 with the FDA Devices before acting.
The recall
Alere San Diego, Inc. issued this moderate-severity FDA Devices recall-There is a potential that the Cholestech LDX battery (an external battery pack available as an optional acces….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1702-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1702-2024) was formally reported on May 8, 2024, with the manufacturer initiating the action on March 1, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Alere San Diego, Inc. is listed as the recalling firm, operating out of San Diego, CA. Federal records list the affected scope as 559 units.
The documented reason for this recall is: 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 curren… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of United Kingdom, Netherlands and Kenya.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
559 units
Related Recalls
6
3 from same agency
Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1702-2024 |
| Date reported | May 8, 2024 |
| Date initiated | March 1, 2024 |
| Recalling firm | Alere San Diego, Inc. |
| Firm location | San Diego, CA |
| Affected scope | 559 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of United Kingdom, Netherlands and Kenya. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 8, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.