Roche Diagnostics Operations, Inc.: Medical Device Recall in 2013 - (Recall #: Z-2109-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.

Product Classification:

Class II

Date Initiated: August 19, 2013

Date Posted: September 4, 2013

Recall Number: Z-2109-2013

Event ID: 65886

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.

Status: Terminated

Product Quantity: 36,332

Code Information:

Lot Number(s): GDA 048, GDA050, GDA 051, GDA 063

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated