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Alere Cholestech Ldx Analyzer, Alere Cholestech Ldx Lipid Profile - Glu Cassette

by Alere San Diego Inc. Dba Biosite, Innovacon, Hemosen

510(k) K120615

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK120615 Date15 May 2013ClearedStatusActive

Recalls

5 recalls · 2 ongoing · FDA

    • Ongoing Z-1702-2024 FDA Class II initiated 1 Mar 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 burns, cuts or abrasions, or low current electrical shock to the user.

    • Ongoing Z-1508-2022 FDA Class II initiated 24 Jun 2022

    Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bilirubin, at concentrations greater than 2.0 mg/dL (conjugated) or 1.6 mg/dL (unconjugated), can result in low recovery of Triglyceride (TRG) and High-Density Lipoproteins (HDL).

    • Terminated Z-2475-2019 FDA Class II initiated 15 Feb 2019 on shared 510(k) K120615

    The polarity of the output of power supply was reversed. Due to polarity of the output of power supplies being reversed, it renders the power supplies nonfunctional and the analyzer inoperable.

    • Terminated Z-2778-2016 FDA Class III initiated 2 Aug 2016 on shared 510(k) K120615

    Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.

    • Terminated Z-0379-2014 FDA Class III initiated 23 Oct 2013

    Alere initiated a recall of Cholestech LDX Lipid Profile-GLU test cassettes, Catalog Number 10-991, Lot # 320167, becuase an incorrect lot number was printed on the outer 10 pack kit box label. The incorrect Lot # number printed was 321067.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CGA
FDA applicant
Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent