—#121209

Product

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

FDA product code: FMK — Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Number(s): GDA 048, GDA050, GDA 051, GDA 063

Why it was 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.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2013-08-19
Posted by FDA: 2013-08-28
Terminated: 2014-05-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #121209. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.