Recall Z-1114-2013 ยท GJS Test, Time, Prothrombin
Roche Diagnostics Operations, Inc.
CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").
| Date | Apr 15, 2013 (initiated Mar 6, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root 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 da |
| Quantity | 4467 both devices |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093460 | COAGUCHEK XS PRO SYSTEM Roche Diagnostics, Mar 18, 2010 |