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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94190

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
March 01, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Alere San Diego, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170

Z-1702-2024
Recall number
Z-1702-2024
Initiated
March 01, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Alere San Diego, Inc.
Quantity
559 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

All Lots/ UDI:

Distribution pattern

Worldwide distribution - US Nationwide and the countries of United Kingdom, Netherlands and Kenya.