Z-2778-2016 Class III Terminated
FDA device recall Z-2778-2016 was initiated by Alere San Diego, Inc. on Aug 2, 2016 and is designated Class III. Reason for recall: Incorrect expiration date on the magnetic strip that does not match the labeled expiration date. The recall status is terminated (terminated Oct 28, 2016). Affected quantity: 12,951.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 21, 2016
- Initiation Date
- Aug 2, 2016
- Termination Date
- Oct 28, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,951
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.
Reason for Recall
Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.
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
Code Information
Model Number: 10-228 and 14-535 Lot Number: 332994
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2778-2016
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026