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U.S. Department of Health and Human Services

Class 2 Device Recall ACCUCHECK FastClix

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 Class 2 Device Recall ACCUCHECK FastClixsee related information
Date Initiated by FirmAugust 19, 2013
Date PostedAugust 28, 2013
Recall Status1 Terminated 3 on May 12, 2014
Recall NumberZ-2109-2013
Recall Event ID 65886
Product Classification Lancet, blood - Product Code FMK
ProductACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
Code Information Lot Number(s): GDA 048, GDA050, GDA 051, GDA 063
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactTodd Siesky
317-576-2000 Ext. 249
Manufacturer 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.
FDA Determined
Cause 2		Equipment maintenance
ActionOn 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 Commerce36,332
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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