FDAFDA · Food and drugs·Recall number Z-2109-2013
ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
Published September 4, 2013 · Recall initiated: August 19, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Distributor
- Nationwide Distribution
- Lot
- Lot Number(s): GDA 048, GDA050, GDA 051, GDA 063
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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