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.
- Company
- Alere San Diego, Inc.
- Recall Initiated
- August 2, 2016
- Terminated
- October 28, 2016
- Recall Number
- Z-2778-2016
- Quantity
- 12,951
- Firm Location
- San Diego, CA
Reason for Recall
Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.
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
Lot / Code Info
Model Number: 10-228 and 14-535 Lot Number: 332994
Root Cause
Packaging
Action Taken
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.