ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).
Reported: April 24, 2013 Initiated: March 6, 2013 #Z-1113-2013
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.
Details
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Units Affected
- Both devices 4467
- Distribution
- Nationwide Distribution.
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).. Recalled by Roche Diagnostics Operations, Inc.. Units affected: Both devices 4467.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2013. Severity: Moderate. Recall number: Z-1113-2013.
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