FDA-Device2013-09-04Class II
ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
Roche Diagnostics Operations, Inc.
Hazard
Internal Roche inspections have revealed that after the lancet is used for a finger stick, the needle may not fully retract back within the lancet drum or back into the cap. This allows the needle to protrude inside the cap or outside of the cap of the ACCU-CHEK FastClix lancing device.
Sold states
Nationwide Distribution
Affected count
36,332
Manufactured in
9115 Hague Rd, Indianapolis, IN, United States
Products
ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2109-2013Don't want to check this manually?
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