Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250) Recalled by Beckman Coulter Inc. Due to Cross-reactivity testing may not meet the claims indicated...
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
Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators. The assay provides a rapid screening procedure for presence of the analyte in urine.
Quantity: 1610 units
Why Was This Recalled?
Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results.
Where Was This Sold?
This product was distributed to 33 states: AL, AZ, AR, CA, CO, DE, FL, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MS, NV, NJ, NY, NC, OH, OK, OR, PA, SC, TX, VA, WA, WV, WI
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