Allogenix; 의 리콜

Recall

45469

Class 3

Z-0619-2008

2007-10-15

2008-02-14

Terminated

United States

2008-09-25

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65547

Unapproved testing: interpore cross international was recently informed that one of its human tissue suppliers, lifelink tissue bank ("lifelink"), utilized unapproved diagnostic testing (hbsag & hbc) on certain lots of distributed donor tissue instead of the fda approved screening test. as a result, interpore cross international has initiated a recall on specific lots of products containing human.

The Recall Notification letters will be sent via commercial carrier (UPS) with signature for verification of receipt required on Friday October 26, 2007, to all consignees, including hospitals and sales representatives, which summarizes the recall details and instructs the consignee to contact Interpore Cross via mail or facsimile with the enclosed Customer Response form, and to immediately return the affected product.