Hologic, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0676-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 29, 2017

Date Posted: February 28, 2018

Recall Number: Z-0676-2018

Event ID: 78832

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.

Status: Terminated

Product Quantity: 165 kits

Code Information:

K6030, L6010, M6007, M6032, A7024, A7056, B7017, B7042, B7057, C7053, D7008, D7043, E7058, E7082

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated