Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ARIES C. difficile Assay Recalled by Luminex Corporation Due to Through internal investigation, it was discovered that a...
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 Luminex Corporation directly.
Affected Products
ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
Quantity: N/A
Why Was This Recalled?
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
Where Was This Sold?
This product was distributed to 34 states: AL, AK, AZ, CA, CO, FL, GA, IL, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NJ, NM, NY, NC, OH, OR, PA, TN, TX, UT, VT, VA, WA, WI
About Luminex Corporation
Luminex Corporation has 39 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report