Recall of Device Recall CEP 8 (D8Z2) SpectrumGreen Probe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Molecular.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 3
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Reagents,specific,analyte - Product Code MVU
  • 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.


  • Model / Serial
    List Number: 06J37-018; Lot Number: 440023
  • Product Classification
  • Device Class
  • Implanted device?
  • 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
  • Product 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.
  • Manufacturer


  • Manufacturer Address
    Abbott Molecular, 1300 E Touhy Ave, Des Plaines IL 60018-3315
  • Source