Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-2778-2016

August 02, 2016

Class III

Product summary

Firm
Alere San Diego, Inc.
Event
Event 74940
Status
Terminated
Classification
Class III
Quantity
12,951
Official record key
device-enforcement:Z-2778-2016

Official wording

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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