Hologic, Inc. recalls Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200

Recalled February 28, 2018 · FDA recall Z-0676-2018 · Hologic

Hazard

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. · FDA Class II

Units

165 kits

Sold at

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

Description

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.

Product

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

Manufacturer(s)

Hologic, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →