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Class 3 Device Recall CEP 8 (D8Z2) SpectrumGreen Probe |
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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
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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
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For Additional Information Contact |
Ms. Jean Leete 224-224-2955
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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.
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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
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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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