Cholestech LDX Lipid Profile"GLU test cassettes, Catalog Number 10-991, Lot # 245104 Cholestech LDX Lipid-Glucose tests
FDA device recall Z-2402-2011 · posted 2011-06-01 · Terminated
Recall details
- Recalling firm
- Biosite Inc Dba Innovacon Inc.
- 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.
- Action taken
- 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.
- Root cause
- Pending
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 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
- Date initiated
- 2011-02-18
- Date posted
- 2011-06-01
- Date terminated
- 2012-04-02
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST (K904082) | Cholestech Corp. | 1990-12-26 |