CLASS II Device recall · Reported 4 Sep 2013 · FDA Enforcement Report
Accu-check FastClix Lancing Device recalled
Roche Diagnostics Operations is recalling Accu-check FastClix Lancing Device, distributed nationwide in the US. The recall was initiated on 19 Aug 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2109-2013
- FDA event ID
- 65886
- Recalling firm
- Roche Diagnostics Operations, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Aug 2013
- FDA classified
- 28 Aug 2013
- Reported
- 4 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Processing Deviation
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 19 Aug 2013 | Recall initiated by company | |
| 28 Aug 2013 | Classified by FDA | +9 days |
| 4 Sep 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
Where it was distributed
Nationwide Distribution
Questions about this recall
Is Accu-check FastClix Lancing Device recalled?
Yes. Roche Diagnostics Operations recalled Accu-check FastClix Lancing Device on 19 Aug 2013. The recall is Class II and its status is Terminated. Recall number Z-2109-2013.
Why was it recalled?
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.
Which lots are affected?
Lot Number(s): GDA 048, GDA050, GDA 051, GDA 063
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Roche Diagnostics Operations
All 127| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | cobas pro integrated solutions recalled by Roche Diagnostics Operations | Roche Diagnostics Operations | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | The Elecsys Anti-TSHR immunoassay is a three-step recalled | Roche Diagnostics Operations | Particulate Matter | Nationwide |
| Device | CLASS II | cobas HCYS, Homocysteine Enzymatic Assay, Material Number recalled | Roche Diagnostics Operations | Potency & Assay | 8 states |
| Device | CLASS II | Creatine Kinase (CK) used on cobas c 311/501/502 recalled | Roche Diagnostics Operations | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Tina-quant D-Dimer Test System recalled by Roche Diagnostics Operations | Roche Diagnostics Operations | Potency & Assay | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 459| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Lead & Heavy Metals | Nationwide |