Z-1114-2013 Class II Terminated
FDA device recall Z-1114-2013 was initiated by Roche Diagnostics Operations, Inc. on Mar 6, 2013 and is designated Class II. 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… The recall status is terminated (terminated Jan 10, 2018). Affected quantity: 4467 both devices.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 24, 2013
- Initiation Date
- Mar 6, 2013
- Termination Date
- Jan 10, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4467 both devices
Product Description
CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").
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.
Distribution Pattern
Nationwide Distribution.
Code Information
catalog number 05530199160
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1114-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026