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

Recall Z-2170-2012 — i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and a

U.S. FDA — Device Enforcement · United States · 2012-02-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2170-2012
Date of alert: 2012-02-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Abbott Point Of Care Inc.
Product category: device
Product type: Devices

Reported risk: The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.

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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