Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CF InPlex ASR Card Recalled by Hologic, Inc Due to Complaints of false positive HET mutations and leaking...
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
CF InPlex ASR Card; Catalog Number: 95-0501.
Quantity: 2580 total
Why Was This Recalled?
Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.
Where Was This Sold?
This product was distributed to 30 states: AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, ME, MA, MI, MO, NJ, NY, NC, OH, OK, OR, PA, RI, TX, WA, WV
About Hologic, Inc
Hologic, Inc has 24 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report