Z-2402-2011

Cholestech LDX Lipid Profile"GLU test cassettes, Catalog Number 10-991, Lot # 245104 Cholestech LDX...

Name: Z-2402-2011 Cholestech LDX Lipid Profile"GLU test cassettes, Catalog Number 10-991, Lot # 245104 Cholestech LDX...
Creator: Biosite Inc Dba Innovacon Inc.
Published: 2011-02-18
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2011-02-18 / Terminated / root cause: manufacturing process

FDA source

Biosite Inc Dba Innovacon Inc. began a recall of Cholestech LDX Lipid Profile"GLU test cassettes, Catalog Number 10-991, Lot # 245104 Cholestech LDX Lipid-Glucose tests are intended for the quantitative... on 2011-02-18. The reason FDA records is "The recall was initiated due to an issue related to an error in the encoding of calibration coefficients in the sample cassette that cause the Cholestech LDX analyzer to report glucose values as >500 mg/dL regardless of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2402-2011
Status: Terminated
Initiated: 2011-02-18
Posted: 2011-06-01
Terminated: 2012-04-02
Recalling firm: Alere San Diego, Inc.
Product: Cholestech LDX Lipid Profile"GLU test cassettes, Catalog Number 10-991, Lot # 245104 Cholestech LDX Lipid-Glucose tests are intended for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides, and/or glucose in whole blood, serum, and plasma. A TC/HDL (total cholesterol/HDL cholesterol) ratio and estimated values for LDL (lowdensity lipoprotein) and non-HDL cholesterol are calculated by the Cholestech LDX.
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: The recall was initiated due to an issue related to an error in the encoding of calibration coefficients in the sample cassette that cause the Cholestech LDX analyzer to report glucose values as >500 mg/dL regardless of the true value of the specimen.
Root cause tag: manufacturing process
FDA root cause: Pending
Action: Alere San Diego, Inc ( formerly known as Biosite Incorporated sent an URGENT MEDICAL DEVICE RECALL letter on February 18, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. Customers were requested to: (1) Discontinue use and/or sale of Cholestech LDX Lipid Profile-GLU test cassettes, Catalog Number 10-991, Lot # 245104. (2) Discard in accordance with your local regulations, all units of the above listed product. (3) Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. (4) If you have forwarded the product listed above to another laboratory, please provide a copy of this letter to them. (5) Complete and FAX the enclosed Verification Form within 10 days to confirm your receipt of this notice, to indicate the number of boxes of test cassettes discarded from your inventory and replacement product will be sent to you. For questions about the information contained in this notification, customers were instructed to contact Alere Technical Services at 1-877-308-8289 (24 hours a day, 7 days a week) or via e-mail at [email protected].
Quantity in commerce: 5,305 Boxes
Distribution: Worldwide Distribution - USA ( nationwide ) including the countries of South America ( EL Salvador) , Europe ( Denmark, France, Norway and Switzerland), Bahrain, Kuwait, South Africa, and United Arab Emirates.
Product codes and lots: Lot # 245104

Product code CGA

K904082Class IICholestech Lipid Monitoring System, Glucose TestCholestech Corp. / cleared 1990-12-26

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)