Z-0379-2014Class III

Product Brand Name(s): Alere Cholestech LDX Lipid Profile"GLU Test Cassette, Model 10-991. Product Generic...

Name: Z-0379-2014 Product Brand Name(s): Alere Cholestech LDX Lipid Profile"GLU Test Cassette, Model 10-991. Product Generic...
Creator: Alere San Diego, Inc.
Published: 2013-10-23
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2013-10-23 / Terminated / root cause: labeling and UDI

FDA source

Alere San Diego, Inc. began a recall of Product Brand Name(s): Alere Cholestech LDX Lipid Profile"GLU Test Cassette, Model 10-991. Product Generic Name: Alere Cholestech LDX Lipid Profile"GLU Test... on 2013-10-23. FDA classified it as Class III and gives the reason as "Alere initiated a recall of Cholestech LDX Lipid Profile-GLU test cassettes, Catalog Number 10-991, Lot # 320167, becuase an incorrect lot number was printed on the outer 10 pack kit box label. The incorrect Lot #...". 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-0379-2014
Classification: Class III
Status: Terminated
Initiated: 2013-10-23
Posted: 2013-11-22
Terminated: 2014-09-25
Recalling firm: Alere San Diego, Inc.
Product: Product Brand Name(s): Alere Cholestech LDX Lipid Profile"GLU Test Cassette, Model 10-991. Product Generic Name: Alere Cholestech LDX Lipid Profile"GLU Test Cassette. Description of the product: Lipid. Glucose panel Test cassettes. Product packaging: 10 individually pouched cassettes in a labeled kit box. Intended for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides, and/or glucose in whole blood, serum, and plasma.
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: Alere initiated a recall of Cholestech LDX Lipid Profile-GLU test cassettes, Catalog Number 10-991, Lot # 320167, becuase an incorrect lot number was printed on the outer 10 pack kit box label. The incorrect Lot # number printed was 321067.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Alere initiated this recall by sending out notification letters to customers via fax, email, or direct mail. The letter titled "URGENT MEDICAL DEVICE NOTICE", dated October 23, 2013 is accompanied by a response form/Verification form. The notification informed customers of the reason for recall, product description with codes, required actions by the customers, and contact information.
Quantity in commerce: 3,621 kits
Distribution: Worldwide Distribution: USA (nationwide) and Internationally to Canada.
Product codes and lots: Model Number: 10-991. Lot #320167. Expiration date, or Expected shelf life: 8/31/14. Expected shelf life: up to 12 months.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0379-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0379-2014	Class III	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-22

Product code CGA

K120615Class IIAlere Cholestech Ldx Analyzer, Alere Cholestech Ldx Lipid Profile - Glu CassetteAlere San Diego Inc. Dba Biosite,Innovacon,Hemosen / cleared 2013-05-15

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)