FDA Device

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

Hazard

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.

What You Should Do

Remedy

On 8/19/ 2013, Roche sent Distributor/Retailer URGENT MEDICAL DEVICE CORRECTION notifications which described the recall issue and health consequences, provided product description, and provided actions required of consignees. Roche sent a CUSTOMER BULLETIN to their direct customers. URGENT MEDICAL DEVICE CORRECTION faxback form for consignee acknowledgement of recall is to be faxed to 1-888-240-2804. Consignees may contact the ACCU-CHEK Customer Care Service Center, 24 hours a day, seven days a week at 1-800-440-3638 if they have questions about the information contained in the Distributor/Retailer Letter.

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Products

ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
Brand
Roche Diagnostics Operations, Inc.
UPC
Lot Number(s): GDA 048, GDA050, GDA 051, GDA 063

Units Affected

36,332

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