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U.S. Department of Health and Human Services

Class 3 Device Recall CEP 8 (D8Z2) SpectrumGreen Probe

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  Class 3 Device Recall CEP 8 (D8Z2) SpectrumGreen Probe see related information
Date Initiated by Firm March 28, 2013
Date Posted April 23, 2014
Recall Status1 Terminated 3 on March 08, 2016
Recall Number Z-1491-2014
Recall Event ID 64791
Product Classification Reagents,specific,analyte - Product Code MVU
Product 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.
Code Information List Number: 06J37-018; Lot Number: 440023
Recalling Firm/
Manufacturer		 Abbott Molecular
1300 E Touhy Ave
Des Plaines IL 60018-3315
For Additional Information Contact Ms. Jean Leete
224-224-2955
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Packaging change control
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.
Quantity in Commerce 20 kits
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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