FDA-Device2023-01-11Class II
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
Beckman Coulter, Inc.
Hazard
Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212
Sold states
US and Canada, Brazil, Korea, Mexico, Puerto Rico, Taiwan
Affected count
3657 units
Manufactured in
11800 Sw 147th Ave, N/A, Miami, FL, United States
Products
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0777-2023Don't want to check this manually?
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