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

Recall Z-2171-2012 — i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (

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-2171-2012
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

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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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