Roche Recalls ACCU-CHEK FastClix Lancing Devices Due to Needle Retraction Defect
Roche Diagnostics is recalling 36,332 ACCU-CHEK FastClix Lancing Devices because the needle may not fully retract after use, posing a puncture risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical defect that poses a risk of puncture injury. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 36,332 units of the ACCU-CHEK FastClix Lancing Device. This device is intended for use in conjunction with a blood glucose monitoring system. The recall covers specific lot numbers: GDA 048, GDA050, GDA 051, and GDA 063.
Internal inspections by Roche 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 defect allows the needle to protrude inside the cap or outside of the cap of the device.
The affected products were distributed nationwide. Consumers should check their devices for the listed lot numbers. If a device is affected, users should stop using it and contact Roche Diagnostics for instructions on return or replacement.
The recalled product
- Product
- ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Hazard
- Affected units
- 36,332
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Number(s): GDA 048
- GDA050
- GDA 051
- GDA 063
Distribution
Distributed nationwide across the United States.
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