Alere San Diego, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2778-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 Classification:

Class III

Date Initiated: August 2, 2016

Date Posted: September 21, 2016

Recall Number: Z-2778-2016

Event ID: 74940

Reason for Recall:

Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.

Status: Terminated

Product Quantity: 12,951

Code Information:

Model Number: 10-228 and 14-535 Lot Number: 332994

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated