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

FDA device recall Z-2109-2013 · posted 2013-08-28 · Terminated

Recall details

Recalling firm

Roche Diagnostics Operations, Inc.

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.

Action taken

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.

Root cause

Equipment maintenance

Status

Terminated

Product code

FMK

Quantity affected

36,332

Distribution

Nationwide Distribution

Date initiated

2013-08-19

Date posted

2013-08-28

Date terminated

2014-05-12

Location

Indianapolis, IN