Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1113-2013 — ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).

U.S. FDA — Device Enforcement · United States · 2013-03-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1113-2013
Date of alert: 2013-03-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Roche Diagnostics Operations, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 05060311001

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1113-2013 — ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).

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