FDA Device recall Z-2169-2012
i-Stat cTnl cartridges Abbott Point of Care Inc
- FDA Device
- Class II
- terminated
- Published 2012-08-15
On 2012-08-15 the FDA classified a Class II recall of i-Stat cTnl cartridges Abbott Point of Care Inc by Abbott Point, citing the frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2169-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-02-01 |
| Published | 2012-08-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Abbott Point |
| Distribution | AZ, CO, GA |
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 and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. The cartridge is to be used with the i-Stat Analyzer, but not with the i-Stat Portable Clinical Analyzer or the Philips Medical System (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-Stat System, the cTnl test is to be used by trained health care professionals in accordance with a facility's policies and procedures.
Reason
The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.
Identifiers
| code_info | List number 06F15-03, 06F15-04, 03P90-23, 600-9009-25 All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2169-2012%22
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