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Recall Observatory FDA recall evidence

Device product

ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.

Z-2109-2013

August 19, 2013

Class II

Product summary

Firm
Roche Diagnostics Operations, Inc.
Event
Event 65886
Status
Terminated
Classification
Class II
Quantity
36,332
Official record key
device-enforcement:Z-2109-2013

Official wording

Reason: 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.

Code information: Lot Number(s): GDA 048, GDA050, GDA 051, GDA 063

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.