FDA-Device2013-04-24Class II
ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).
Roche Diagnostics Operations, Inc.
Hazard
Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards.
Sold states
Nationwide Distribution.
Affected count
Both devices 4467
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1113-2013Don't want to check this manually?
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