Abbott i-Stat cTnl Cartridges Recalled Due to Atmospheric Pressure Effects
Abbott Point of Care Inc. is recalling i-Stat cTnl cartridges because atmospheric pressure affects the frequency of suppressed results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no specific injuries or hospitalizations are reported in the source text.
Plain-English summary
Abbott Point of Care Inc. is recalling i-Stat cTnl cartridges. The i-Stat cTnl test is an in vitro diagnostic test used by trained health care professionals to measure cardiac troponin I in heparinized whole blood or plasma samples. These measurements aid in the diagnosis and treatment of myocardial infarction and risk stratification of patients with acute coronary syndromes.
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. The affected units include 7,057,675 cartridges in the US and 772,400 cartridges outside the US. The distribution was worldwide, including the United States and numerous international locations.
The recall covers all lots with list numbers 06F15-03, 06F15-04, 03P90-23, and 600-9009-25. The cartridges are intended for use with the i-Stat Analyzer but not with the i-Stat Portable Clinical Analyzer or the Philips Medical System Blood Analysis Module. Health care facilities should follow their policies and procedures regarding the use of these devices.
The recalled product
- Product
- i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis…
- Manufacturer
- Abbott Point Of Care Inc.
- Hazard
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 06F15-03
- 06F15-04
- 03P90-23
- 600-9009-25 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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