FDA-Device2016-01-20Class II
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.
Beckman Coulter Inc.
Hazard
Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative.
Sold states
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.
Affected count
16,206 vials total (7,827 vials in US)
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0649-2016Don't want to check this manually?
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