FDA Medical Device Recalls (openFDA)
Biosite Inc Dba Innovacon Inc.: 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.
- Recall number
- Z-2402-2011
- Recalling firm
- Biosite Inc Dba Innovacon 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.
- Status
- Terminated
- Initiated
- 2011-02-18
- Posted
- 2011-06-01
- Terminated
- 2012-04-02
- Reason
- 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
- 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 service.cholestech@alere.com.
- Quantity
- 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.
- Lot, serial or model codes
- Lot # 245104
- 510(k) numbers
- ["K904082"]
- 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