Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Beckman Coulter Recalled by Beckman Coulter Inc. Due to Lipemic interference failed to meet the performance specification...
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 Beckman Coulter Inc. directly.
Affected Products
Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
Quantity: 12,850 units
Why Was This Recalled?
Lipemic interference failed to meet the performance specification listed within the IFU.
Where Was This Sold?
This product was distributed to 42 states: AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, DC
About Beckman Coulter Inc.
Beckman Coulter Inc. has 241 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report