Class 2 Device Recall CoaguChek XS Pro meters

• Date Initiated by Firm: March 06, 2013
• Date Posted: April 15, 2013
• Recall Status: Terminated on January 10, 2018
• Recall Number: Z-1114-2013
• Recall Event ID: 64460
• 510(K)Number: K093460
• Product Classification: Test, time, prothrombin - Product Code GJS
• Product: CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").
• Code Information: catalog number 05530199160
• Recalling Firm/ Manufacturer: Roche Diagnostics Operations, Inc.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: Todd Siesky; 317-576-2000 Ext. 249
• Manufacturer Reason for Recall: Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards. Errors have been confirmed with the EAN 13 barcodes which should not be used for patient or operator identification.
• FDA Determined Cause: Device Design
• Action: Consignees of both devices were notified by Urgent Medical Device Correction letters sent via UPS Ground (receipt required) beginning 3/06/2013. The notice contained recommendation not to use EAN-13 barcode system and ensure barcodes used meet quality standards; use operator and patient lists (downloaded from a data manager) in order to check any decoded identification against the respective list. The notice directed forwarding of the notice if the product was further distributed. Customers were asked to complete the attached fax form. Contact the Customer Care Service Center, 24 hours a day, seven days a week at 1-800-440-3638 for Accu check questions and 1-800-428-4674 for CoaguChek questions about the information contained in this UMDC.
• Quantity in Commerce: 4467 both devices
• Distribution: Nationwide Distribution.
• Total Product Life Cycle: TPLC 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.

• 510(K) Database: 510(K)s with Product Code = GJS