Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-1702-2024 · Posted 2024-04-30

Recalling FirmAlere San Diego, Inc.
Recall StatusOpen, Classified
Product CodeCGA
Date Initiated2024-03-01
Product Quantity559 units

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.

Firm Action

On March 28, 2024, Alere San Diego issued a Urgent Medical Device Correction notification to affected consignees via mail. In addition to informing consignees about the recall, Alere asked consignees to take the following actions: " Inspect all Cholestech LDX" Battery Kits for any signs of swelling. DO NOT CONTINUE USE OF BATTERIES THAT APPEAR SWOLLEN. If your battery pack exhibits any signs of swelling, the product should not be used and discarded per local regulations. " If the battery appears normal, then it can continue to be used. " Complete and return the Customer Reply Form. " If you have forwarded the products listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter. " Please retain this letter for your laboratory records.

Root Cause

Labeling design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120615ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTEAlere San Diego Inc. Dba Biosite,Innovacon,Hemosen · 2013-05-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑