Reported Apr 24, 2013 · Terminated
ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to…
Roche Diagnostics Operations, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Operations, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).
- Lot codes and dates
part number 0506031100105060303001
- Amount recalled
- Both devices 4467
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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