ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2109-2013.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2109-2013.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2109-2013.
Roche Diagnostics Operations, Inc.
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Roche Diagnostics Operations, Inc. Recall FAQ
Roche Diagnostics Operations, Inc. is the subject of a diabetes devices safety report: ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.. The notice was published on August 19, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 36,332 units are potentially affected.