Recall Z-0677-2018

Hologic, Inc. · initiated November 29, 2017

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

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

Codes / lots: E7058

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.

FDA-determined cause: Mixed-up of materials/components

Action taken

Hologic initiated the recall on Wednesday, November 29, 2017. The method of notification was via overnight FedEx.

Details

Recall number
Z-0677-2018
Initiated
November 29, 2017
Terminated
August 22, 2018
Product code
LKV – Enzyme Immunoassay, Fetal Fibronectin
Distribution
United States (US), Guam (GU), Japan (JP)
Recalling firm
Hologic, Inc., Sunnyvale, CA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0676-2018 Class IIRapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products… 11/29/2017Terminated