FDA Medical Device Recalls (openFDA)
Alere San Diego: Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic.
- Recall number
- Z-0964-2012
- Recalling firm
- Alere San Diego
- Product
- Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic.
- Status
- Terminated
- Initiated
- 2010-11-16
- Posted
- 2012-02-06
- Terminated
- 2013-08-22
- Reason
- Alere has identified that a bias on results for certain analytes tested on the Alere Cholestech LDX System may exist due to humidity variability.
- Root cause
- Device Design
- Action
- Alere sent an Updated Urgent Recall Notification Letter in March 2012 to all their customers who are in possession of one or more Cholestech LDX Systems. The updated letter provides the customers with important information about the problem identified and the actions to be taken. Customers are instructed to operate their device in a controlled environment that maintains humidity within 40-60% relative humidity if the device has not been upgraded with ROM pack v3.40. If humidity cannot be monitored, the device is no longer CLIA waived. Customers are instructed to complete the customer verification form. A previous notice from Alere sent in November 2010 instructs users to contact Alere to receive the ROM pack upgrade. Customers may email LDXROM@alere.com to request an electronic form to complete and return via email. Customers can expect their ROM packs approximately 10 to 14 business days after Alere receives their request. If customers have transferred ownership to another party, they can email Alere at LDXROM@alere.com with the updated contact information. If customers are not currently using their Cholestech LDX System, it is recommended that the ROM Pack upgrade be installed prior to restarting use of any Cholestech LDX analyzer. Customers with questions regarding this communication can call Alere at (877) 441-7440, option 1 or email at LDXROM@alere.com.
- Quantity
- 22,000 meters
- Distribution
- Worldwide distribution including USA
- Lot, serial or model codes
- ROM versions prior to 3.40
- 510(k) numbers
- ["K901900"]
- PMA numbers
- not on file
- Product code
- CHH
- 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