Z-2778-2016Class III

LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The...

Name: Z-2778-2016 LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The...
Creator: Alere San Diego, Inc.
Published: 2016-08-02
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2016-08-02 / Terminated / root cause: packaging

FDA source

Alere San Diego, Inc. began a recall of LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics system of the LDX... on 2016-08-02. FDA classified it as Class III and gives the reason as "Incorrect expiration date on the magnetic strip that does not match the labeled expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2778-2016
Classification: Class III
Status: Terminated
Initiated: 2016-08-02
Posted: 2016-09-10
Terminated: 2016-10-28
Recalling firm: Alere San Diego, Inc.
Product: LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer. Product Usage: The Optics Check Cassette is used to check the optics system of the Alere Cholestech LDX Analyzer. It is run once a day before patient samples are tested and after the analyzer has been moved or serviced.
Product code: LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Reason for recall: Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.
Root cause tag: packaging
FDA root cause: Packaging
Action: Alere issued a recall notification to customers via telephone and email. Customers was informed of the affected product, problem and actions to be taken. Customers were instructed if they have the affected lot contact the Alere technical service department at 877-308-8289 to report this lot and receive a free replacement. For questions call 877-308-8289 and reference their specific case number.
Quantity in commerce: 12,951
Distribution: Worldwide Distribution - U.S Nationwide in the states of: TN, MA, GA, OK, VA, FL, TN, MO, AL, TX, IL, NY, VT, RI, KY, WI, AL, NC, LA, SD, TX, VA, MI, MN, IN, IA, CA, AR, PA, HI, WV, KS, CO, CT, UT and the countries of Japan, England, Canada
Product codes and lots: Model Number: 10-228 and 14-535 Lot Number: 332994

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2778-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2778-2016	Class III	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-09

Product code LBS

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