Recall Z-2402-2011 ยท CGA Glucose Oxidase, Glucose
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 lipoprot
| Date | Jun 1, 2011 (initiated Feb 18, 2011) |
| Status | Terminated |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K904082 | CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST Cholestech Corp., Dec 26, 1990 |