FDA Medical Device Recalls (openFDA)
Alere San Diego, Inc.: Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
- Recall number
- Z-1702-2024
- Recalling firm
- Alere San Diego, Inc.
- Product
- Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
- Status
- Open, Classified
- Initiated
- 2024-03-01
- Posted
- 2024-04-30
- Terminated
- not on file
- 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.
- 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
- 559 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of United Kingdom, Netherlands and Kenya.
- Lot, serial or model codes
- All Lots/ UDI:
- 510(k) numbers
- ["K120615"]
- PMA numbers
- not on file
- Product code
- CGA
- Firm FEI
- 1000125596
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28