Z-1113-2013 Class II Terminated
FDA device recall Z-1113-2013 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: Both devices 4467.
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
- Both devices 4467
Product Description
ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).
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.
Distribution Pattern
Nationwide Distribution.
Code Information
part number 05060311001, 05060303001
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1113-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026