Alere San Diego, Inc. recalls LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is use…

Recall date

August 2, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2778-2016

FDA classification

Class III

Brand / firm

Alere San Diego, Inc.

Sold / distributed

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

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.