FDA-Device2019-07-10Class II
iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.
Beckman Coulter Inc.
Hazard
Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.
Sold states
Distribution was nationwide, including Puerto Rico. There was also military/government distribution. Foreign distribution was made to Canada, Argentina, Brazil, Chile, Colombia, Mexico, Peru, Philippines, Singapore, and Taiwan.
Affected count
956,798/100 test strip vials
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1937-2019Don't want to check this manually?
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