FDA recall Z-0677-2018

Product

Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q

Reason for recall

Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material from SDIX.

Distribution

United States (US), Guam (GU), Japan (JP)

Key facts

Status

Terminated

Initiation date

2017-11-29

Report date

2018-02-28

Termination date

2018-08-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sunnyvale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0677-2018