Z-0442-2011

Cholestech LDX Lipid Controls, Level 1 & 2, 3 vial set, Catalog Number 10-983. Assayed quality control...

Name: Z-0442-2011 Cholestech LDX Lipid Controls, Level 1 & 2, 3 vial set, Catalog Number 10-983. Assayed quality control...
Creator: Biosite Inc Dba Innovacon Inc.
Published: 2010-10-06
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2010-10-06 / Terminated

FDA source

Biosite Inc Dba Innovacon Inc. began a recall of Cholestech LDX Lipid Controls, Level 1 & 2, 3 vial set, Catalog Number 10-983. Assayed quality control material for use with the Cholestech LDX System on 2010-10-06. The reason FDA records is "The recall was initiated because results were being reported as being out of range. Firm is reassigning ranges for HDL cholesterol in product". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0442-2011
Status: Terminated
Initiated: 2010-10-06
Posted: 2010-11-22
Terminated: 2012-08-01
Recalling firm: Alere San Diego, Inc.
Product: Cholestech LDX Lipid Controls, Level 1 & 2, 3 vial set, Catalog Number 10-983. Assayed quality control material for use with the Cholestech LDX System.
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: The recall was initiated because results were being reported as being out of range. Firm is reassigning ranges for HDL cholesterol in product.
FDA root cause: Pending
Action: All customers were notified and given instructions, requirements, and expectations for their role in the Correction activities using the Notice of Correction with attached Returned Verification Forms which were supplied via fax, email or direct mail beginning on October 6, 2010. Customers are to share the information provided in the Notice with their laboratory staff and retain the letter as part of their laboratory Quality System documentation. If any affected product had been further distributed to another laboratory, then a copy of the letter should be provided to them. Customers are to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice. Consignees with questions about the information contained in the notification were instructed to contact: Alere San Diego, Inc. 9975 Summers Ridge Road San Diego, CA 92121 U.S.A. Phone: 877 441 7440 FAX: 858 805 8457 E-mail: [email protected]
Quantity in commerce: 917 kits
Distribution: Worldwide Distribution -- USA, Australia, Canada, Great Britain, India, Italy, Mexico, Norway, Puerto Rico, South Korea, Spain, Switzerland, and Trinidad & Tobago.
Product codes and lots: Lot # SC0146

Product code JJY

K913687Class IChem-ChexStreck Laboratories, Inc. / cleared 1991-09-19

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)