ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner — Class II medical device recall Z-1113-2013
Terminated recall by Roche Diagnostics Operations, Inc., reported 2013-04-24, distributed nationwide. Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading mete
| Recall number | Z-1113-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2013-03-06 |
| Classified | 2013-04-15 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2018-01-10 |
| Distributed | Nationwide (US) |
| Quantity | 4,467 |
| Model numbers | 05060303001, 05060311001 |
Product
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.