FDA Device recall Z-2109-2013
ACCU-CHECK FastClix Lancing Device
- FDA Device
- Class II
- terminated
- Published 2013-09-04
On 2013-09-04 the FDA classified a Class II recall of ACCU-CHECK FastClix Lancing Device by Roche Diagnostics Operations, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2109-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-19 |
| Published | 2013-09-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
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.
Identifiers
| code_info | Lot Number(s): GDA 048, GDA050, GDA 051, GDA 063 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2109-2013%22
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