Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Rapid for the TLiIQ(R) System Recalled by Hologic, Inc. Due to Rapid fFN cassettes were manufactured with material (A137...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hologic, Inc. directly.
Affected Products
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q
Quantity: N/A
Why Was This 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.
Where Was This Sold?
United States (US), Guam (GU), Japan (JP)
About Hologic, Inc.
Hologic, Inc. has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report