Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reage

FDA device recall Z-0595-2007 · posted 2007-03-13 · Terminated

Recall details

Recalling firm

Abbott Molecular

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

MVU

Quantity affected

109 probe sets

Distribution

Worldwide including USA, Austria, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Spain, and the United Kingdom.

Date initiated

2006-12-22

Date posted

2007-03-13

Date terminated

2008-04-17

Location

Des Plaines, IL