Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 01166 Rapid fFN Control Kit

FDA device recall Z-1661-2011 · posted 2011-03-16 · Terminated

Recall details

Recalling firm

Cytyc Prenatal Products/Hologic Inc.

Reason for recall

Product name change requires conversion to a different type of PMA and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict imminent delivery in women who are at full term gestation.

Action taken

The firm, Hologic, sent a "Important-Product Recall/Correction" letter dated December 18, 2009 to its customers. The letter described the product, problem and the actions to be taken. The customers were instructed to 1) replace the directional inserts for the specimen collection kit and health care providers' brochure with provided instructions, 2) over-label specimen collection kit boxes with provided stickers and individual kits, 3) permanently destroy any marketing and educational materials with the "full term" name and 4) complete and return the CUSTOMER RECALL RESPONSE FORM via fax at 408-744-1905 or scan and email to recallfullterm@hologic.com. If you have any questions about this notification, please contact the Hotline (800-442-9892, Option 7# or 508-263-8510).

Root cause

PMA

Status

Terminated

Product code

lkv

Distribution

Worldwide distribution.

Date initiated

2009-12-15

Date posted

2011-03-16

Date terminated

2011-03-16

Location

Sunnyvale, CA