Z-1114-2013Class II

CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to...

Name: Z-1114-2013 CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to...
Creator: Roche Diagnostics Operations, Inc.
Published: 2013-03-06
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2013-03-06 / Terminated / root cause: design

FDA source

Roche Diagnostics Operations, Inc. began a recall of CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT") on 2013-03-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1114-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-06
Posted: 2013-04-15
Terminated: 2018-01-10
Recalling firm: Roche Diagnostics GmbH
Product: CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").
Product code: GJS Test, Time, Prothrombin
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.
Root cause tag: design
FDA 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 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.
Product codes and lots: catalog number 05530199160

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1114-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1113-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-15
Z-1114-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-15

Product code GJS

K093460Class IICoaguchek Xs Pro SystemRoche Diagnostics / cleared 2010-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)