Abbott i-Stat CK-MP Cartridges Recalled for Atmospheric Pressure Interference
Abbott Point of Care Inc. is recalling i-Stat CK-MP cartridges because atmospheric pressure can cause suppressed test results, potentially affecting the diagnosis of myocardial infarction.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk diagnostic product where inaccurate results could impact the diagnosis of myocardial infarction, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Abbott Point of Care Inc. is recalling i-Stat CK-MP cartridges. The i-Stat CKMB test is an in vitro diagnostic test used to measure creatinine kinase MB mass in whole blood or plasma samples, which serves as an aid in the diagnosis and treatment of myocardial infarction (MI).
The recall is being conducted because the frequency of suppressed results for i-Stat cTnl, BNP, and CK-MP cartridges is affected by atmospheric pressure. This interference may lead to inaccurate test readings.
The recall affects 368,149 cartridges in the US and 32,725 cartridges outside the US. Distribution was worldwide, including the United States (specifically Arizona and Colorado) and numerous international locations. The recall includes list numbers 06F25-01, 06F25-02, and 03P92-25, covering all lots.
The recalled product
- Product
- 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 myo
- Manufacturer
- Abbott Point Of Care Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- List number 06F25-01
- 06F25-02
- 03P92-25
- All lots
Distribution
Part of a larger recall action
This product is one of 3 recalled by Abbott Point Of Care Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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