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U.S. Department of Health and Human Services

Class 3 Device Recall Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set

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  Class 3 Device Recall Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set see related information
Date Initiated by Firm December 22, 2006
Date Posted March 13, 2007
Recall Status1 Terminated 3 on April 17, 2008
Recall Number Z-0595-2007
Recall Event ID 37363
Product Classification in vitro diagnostic - Product Code MVU
Product Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reagents, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 05J83-001;

The probe set consists of a 200 microliter vial of Vysis LSI D13S319 SO/LSI 13q34 SA/CEP 12 SG Probe, reference 30-191024, and a 200 microliter vial of Vysis LSI ATM SG/p 53 SO Probe, reference 30-191025.
Code Information list 05J83-001, part number 32-191025, lot numbers 79500, exp. 8-9-08 and 80178, exp.10-16-08
Recalling Firm/
Manufacturer		 Abbott Molecular
1300 E Touhy Ave
Des Plaines IL 60018-3315
For Additional Information Contact Mr. Donald B. Braakman
224-361-7246
Manufacturer Reason
for Recall		 The LSI D13S319 SO/13q34 SA/CEP 12 SG probe of the two mixture DNA-Probe was contaminated with LSI ATM SG/p53 SO probe. This contamination would result in 10 FISH signals in each normal cell rather than the expected 6 FISH signals in each normal cell.
FDA Determined
Cause 2		 Other
Action Abbott Molecular telephoned and/or sent recall letters to the Abbott FISH accounts on 12/22/06, advising them that an unexpected signal pattern with the Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 Probe was observed, confirmed and identified as a result of contamination in a subset of vials of D13S319 /CEP 12/13q34 from lot number 79500. This contamination results in 10 FISH signals in each normal cell (4 SO, 4 SG, 2 SA) rather than the expected 6 FISH signals in each normal cell (2 SO, 2 SG, 2 SA). The customers were advised that lot 80178 was also being included in the recall, and were requested to review the information carefully and assess the risk to their patient population; discontinue and destroy any unused product immediately; complete and return the enclosed reply form; review the information with laboratory personnel; and communicate the information to health care providers served in cases where the affected product were used and reported. Abbott Molecular provided replacement product for that product destroyed, upon receipt of the reply form. Any questions were directed to Abbott Molecular Technical Service at 800-553-7042, option 2.
Quantity in Commerce 109 probe sets
Distribution Worldwide including USA, Austria, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Spain, and the United Kingdom.
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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