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

Recall date

November 29, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0676-2018

FDA classification

Class II

Brand / firm

Hologic, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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