Z-2109-2013 Class II Terminated
FDA device recall Z-2109-2013 was initiated by Roche Diagnostics Operations, Inc. on Aug 19, 2013 and is designated Class II. 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… The recall status is terminated (terminated May 12, 2014). Affected quantity: 36,332.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 4, 2013
- Initiation Date
- Aug 19, 2013
- Termination Date
- May 12, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36,332
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.
Distribution Pattern
Nationwide Distribution
Code Information
Lot Number(s): GDA 048, GDA050, GDA 051, GDA 063
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2109-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026