Z-0964-2012

Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic

Name: Z-0964-2012 Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic
Creator: Alere San Diego
Published: 2010-11-16
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2010-11-16 / Terminated / root cause: design

FDA source

Alere San Diego began a recall of Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic on 2010-11-16. The reason FDA records is "Alere has identified that a bias on results for certain analytes tested on the Alere Cholestech LDX System may exist due to humidity variability". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0964-2012
Status: Terminated
Initiated: 2010-11-16
Posted: 2012-02-06
Terminated: 2013-08-22
Recalling firm: Alere San Diego, Inc.
Product: Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic.
Product code: CHH Enzymatic Esterase--Oxidase, Cholesterol
Reason for recall: 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 tag: design
FDA 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 [email protected] 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 [email protected] 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 [email protected].
Quantity in commerce: 22,000 meters
Distribution: Worldwide distribution including USA
Product codes and lots: ROM versions prior to 3.40

Product code CHH

K901900Class IL.d.x Lipid Monitoring SystemCholestech Corp. / cleared 1990-07-24

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)