Z-0747-2013Class III

Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX...

Name: Z-0747-2013 Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX...
Creator: Alere San Diego, Inc.
Published: 2012-10-22
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2012-10-22 / Terminated / root cause: design

FDA source

Alere San Diego, Inc. began a recall of Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL... on 2012-10-22. FDA classified it as Class III and gives the reason as "Out of range (increased) HDL Cholesterol results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0747-2013
Classification: Class III
Status: Terminated
Initiated: 2012-10-22
Posted: 2013-01-29
Terminated: 2013-09-26
Recalling firm: Alere San Diego, Inc.
Product: Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), and glucose (GLU) test procedures on the Alere Cholestech LDX System. Calibration verification is optional for CLIA waived systems, such as the Alere Cholestech LDX System, under CLIA regulations. However local or state regulations may require that calibration verification is run at regular intervals.
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: Out of range (increased) HDL Cholesterol results.
Root cause tag: design
FDA root cause: Component design/selection
Action: A recall letter was sent on 10/22/12 to all customers who purchased the Alere Cholestech LDX Mutianalyte Control, 2 vial set, Catalog Number 88769, Lot #C2510 & Lot #C2510A. The letter informed the customers that these lots of controls may yield results which are out of range high for the Level 2 control when tested with the Alere Cholestech LDX HDL test. Customers are instructed of the actions to be taken. On 11/16/12, the recall expanded to include the Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog 88770, Lot#271097. The problem identified is that these lots of calibration verification materials may yield results which are out of range high when tested with the Alere Cholestech LDX HDL test. Customers are instruted of the actions to be taken. On 3/6/13, the recall expanded to include the Alere Cholestech LDX Calibration Verification, 4 Vial set, Catalog # 88770, Lot#298148 and 301886. The recall expanded to include the Alere Cholestech LDX Multianalyte Control, 2 vial Set, Catalog # 88769, Lots#C2572, C2572A, C2593 and C2593A. Customers are instructed to complete and fax the enclosed verification form within 10 days. Customers with questions are instructed to contact Alere San Diego, 9975 Summers Ridge Rd, San Diego, CA 92121, (877) 308-8289, fax (858) 805-8457, and [email protected].
Quantity in commerce: 614 kits
Distribution: Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea.
Product codes and lots: Lot#271097, 298148, and 301886

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0747-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0746-2013	Class III	Terminated	Voluntary: Firm initiated	2013-02-06	2013-01-29
Z-0747-2013	Class III	Terminated	Voluntary: Firm initiated	2013-02-06	2013-01-29

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)