Z-0122-2016Class III

Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of...

Name: Z-0122-2016 Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of...
Creator: Alere San Diego, Inc.
Published: 2015-08-27
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2015-08-27 / Terminated / root cause: labeling and UDI

FDA source

Alere San Diego, Inc. began a recall of Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein... on 2015-08-27. FDA classified it as Class III and gives the reason as "Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride (TRG) analytes are incorrect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0122-2016
Classification: Class III
Status: Terminated
Initiated: 2015-08-27
Posted: 2015-10-15
Terminated: 2015-12-22
Recalling firm: Alere San Diego, Inc.
Product: Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test procedures.
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride (TRG) analytes are incorrect.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Customer notification letters dated 8/25/15 and 9/3/15 were sent to customers to inform them that Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride (TRG) analytes are incorrect. Customers are informed that the Alere Cholestech LDX Total Cholesterol and Triglyceride assays continue to perform as expected. However, if customers' facility has used the control lot to test Total Cholesterol or Triglycerides as part of their Quality Control program, Alere San Diego recommends that they verify previous results or perform control testing using the replacement Expected Value Card or replacement control materials. The letters also provide customers with actions to be taken. Customers with questions are instructed to contact: Alere San Diego, Inc. 9975 Summers Ridge Road San Diego, CA 92121 U.S.A. Phone: 877-308-8289, FAX: 866-333-9839, E-mail: [email protected].
Quantity in commerce: 190 kits
Distribution: Nationwide Distribution.
Product codes and lots: Lot C3091 and Lot C3091A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0122-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0122-2016	Class III	Terminated	Voluntary: Firm initiated	2015-10-21	2015-10-15

Product code JJY

K102700Class ILipid Controls; Multi- Analyte Control; Multi-Analyte Calibration Verification MaterialsAlere, San Diego, Dba Biosite INcorporated, Dba IN / cleared 2010-12-21

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)