Z-2109-2013Class II

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

Name: Z-2109-2013 ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring...
Creator: Roche Diagnostics Operations, Inc.
Published: 2013-08-19
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2013-08-19 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Operations, Inc. began a recall of ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system on 2013-08-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2109-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-19
Posted: 2013-08-28
Terminated: 2014-05-12
Recalling firm: Roche Diagnostics GmbH
Product: ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
Product code: FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 36,332
Distribution: Nationwide Distribution
Product codes and lots: Lot Number(s): GDA 048, GDA050, GDA 051, GDA 063

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2109-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2109-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-28

Product code FMK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)