Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
iChem 10 SG Urine Chemistry Strips Recalled by Beckman Coulter Inc. Due to Iris International is recalling the iChem 10 SG...
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
iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color.
Quantity: 16,206 vials total (7,827 vials in US)
Why Was This Recalled?
Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative.
Where Was This Sold?
Worldwide Distribution -- US, Brazil, Canada, Chile, Ecuador, France, Germany, Greece, Italy, Kuwait, Luxembourg, Malaysia, Philippines, Portugal, Puerto Rico, Singapore, Spain, Switzerland, Turkey, and United Arab Emirates.
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