Recall Z-2109-2013— Roche Diagnostics Operations, Inc.
Class II · Terminated
Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2013-08-19, terminated 2014-05-12. FDA's recall record names no specific 510(k) clearance for this event. Product: ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.. 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..
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-19
- Terminated
- 2014-05-12
- Firm location
- Indianapolis, IN, United States
Product description
ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.