BEUDAMED
    FDA Recall Terminated

    The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe and a Certificate of Analysis (COA). Chromosome enumeration probes (CEP) are chromosome-specific FISH probes that hybridize to highly repetitive human satellite DNA sequences, usually located near centromeres. CEP signals enable the identification and enumeration of human chromosomes in interphase and metaphase cells from fresh and archived samples. The label for CEP 8 SG ASR Probe Kit indicates it is an Analyte Specific Reagent, and analytical and performance characteristics are not established.

    Recall: Z-1491-2014 · Initiated March 28, 2013

    Recall

    Recall Number
    Z-1491-2014
    Event Number
    64791
    Firm
    Abbott Molecular
    FEI Number
    3005248192
    Product Code
    MVU
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    March 28, 2013
    Posted
    April 23, 2014
    Terminated
    March 8, 2016
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315

    Description

    The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe and a Certificate of Analysis (COA). Chromosome enumeration probes (CEP) are chromosome-specific FISH probes that hybridize to highly repetitive human satellite DNA sequences, usually located near centromeres. CEP signals enable the identification and enumeration of human chromosomes in interphase and metaphase cells from fresh and archived samples. The label for CEP 8 SG ASR Probe Kit indicates it is an Analyte Specific Reagent, and analytical and performance characteristics are not established.

    Reason

    20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellite) SG Probe, 20u, (part 32-112004 lot 438814), instead of the expected CEP 8 probe.

    Action

    Customers were sent Field Correction Notices dated 3/28/13 instructing them to inspect their CEP 8 SpectrumGreen Probe kits for the presence of CEP4 probe vials. If any CEP4 vials are discovered, customers should contact their local Abbott Molecular Technical Support Represtative for coordination of reagent replacement with the correct CEP8 vial. If customers have any specific questions they can contact Abbott Molecular at 1-800-553-7042, Option 2.

    Distribution

    Nationwide (CA, CO, CT, FL, HI, IL, IN, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, TN, TX, VA, WA, WI); Canada

    Quantity

    20 kits