Z-1702-2024Class II

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

Name: Z-1702-2024 Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
Creator: Alere San Diego, Inc.
Published: 2024-03-01
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2024-03-01 / Open, Classified / root cause: labeling and UDI

FDA source

Alere San Diego, Inc. began a recall of Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 on 2024-03-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1702-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-01
Posted: 2024-04-30
Recalling firm: Alere San Diego, Inc.
Product: Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
Product code: CGA Glucose Oxidase, Glucose
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
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.
Quantity in commerce: 559 units
Distribution: Worldwide distribution - US Nationwide and the countries of United Kingdom, Netherlands and Kenya.
Product codes and lots: All Lots/ UDI:

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1702-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1702-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-04-30

Product code CGA

K120615Class IIAlere Cholestech Ldx Analyzer, Alere Cholestech Ldx Lipid Profile - Glu CassetteAlere San Diego Inc. Dba Biosite,Innovacon,Hemosen / cleared 2013-05-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)