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FDANovember 29, 2017device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

hologic

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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