Home / Recalls / Alere San Diego, Inc. / Z-2778-2016

Z-2778-2016 Class III Terminated

Recalled by Alere San Diego, Inc. — San Diego, CA

Recall Details

Product Type
Devices
Report Date
September 21, 2016
Initiation Date
August 2, 2016
Termination Date
October 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

Other recalls by Alere San Diego, Inc.

  • Z-1702-2024 Class II — Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 (March 1, 2024)
  • Z-1508-2022 Class II — The Cholestech LDX¿ System combines enzymatic methodology and solidphase techno (June 24, 2022)
  • Z-2475-2019 Class II — Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the (February 15, 2019)
  • Z-0418-2018 Class II — Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 2 (November 14, 2017)
  • Z-0588-2017 Class II — Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the prod (October 12, 2016)
  • Z-2360-2016 Class I — Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Pr (July 11, 2016)
  • Z-2354-2016 Class I — Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usag (July 11, 2016)
  • Z-2357-2016 Class I — Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Prod (July 11, 2016)
  • Z-2361-2016 Class I — Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usag (July 11, 2016)
  • Z-2359-2016 Class I — Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usag (July 11, 2016)