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U.S. Department of Health and Human Services

Class 2 Device Recall CoaguChek XS Pro meters

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 Class 2 Recall
CoaguChek XS Pro meters
see related information
Date Posted April 15, 2013
Recall Status1 Open
Recall Number Z-1114-2013
Recall Event ID 64460
Premarket Notification
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, Indiana 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 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GJS and Original Applicant = Roche Diagnostics
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