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