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

Recall Z-1211-2014 — FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperature below 86 degrees F (30 degrees C). Use test strips only within the system operating temperature range as outlined in your Owner's Booklet. Meter made in China; Distributed by Abbott Diabetes

U.S. FDA — Device Enforcement · United States · 2014-02-19 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1211-2014
Date of alert: 2014-02-19
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Abbott Diabetes Care, Inc.
Product category: device
Product type: Devices

Reported risk: Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when used in conjunction with Free Style test strips lots within expiry.

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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