FDAClass IISeptember 4, 2013

ACCU-CHECK FastClix Lancing Device. It is intended for recall

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

Why was ACCU-CHECK FastClix Lancing Device. It is intended for 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number(s): GDA 048, GDA050, GDA 051, GDA 063

Product
ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
Recalling firm
Roche Diagnostics Operations, Inc.
Quantity
36,332
Distribution
Nationwide Distribution
Recall date
September 4, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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