FDA Medical Device Recalls (openFDA)
Roche Diagnostics Operations, Inc.: ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
- Recall number
- Z-2109-2013
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Product
- ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
- Status
- Terminated
- Initiated
- 2013-08-19
- Posted
- 2013-08-28
- Terminated
- 2014-05-12
- Reason
- 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
- Equipment maintenance
- Action
- 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.
- Quantity
- 36,332
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot Number(s): GDA 048, GDA050, GDA 051, GDA 063
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMK
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28