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

Recall Z-1245-2013 — FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx

U.S. FDA — Device Enforcement · United States · 2013-04-15 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1245-2013
Date of alert: 2013-04-15
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Abbott Diabetes Care, Inc.
Product category: device
Product type: Devices

Reported risk: AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.

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.

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