Recall Z-1702-2024— Alere San Diego, Inc.

Name: FDA recall Z-1702-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-01

Class II · Ongoing

Class II FDA medical device recall by Alere San Diego, Inc., initiated 2024-03-01. It names one FDA 510(k) clearance: K120615. Product: Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170. Reason: 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..

Recalling firm: Alere San Diego, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-03-01
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K120615 — ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTEAlere San Diego Inc. Dba Biosite,Innovacon,Hemosen·cleared 2013-05-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.