FDA Device recall Z-2171-2012
i-Stat CK-MP 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 CK-MP 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-2171-2012 |
| 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 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 (MI).
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 06F25-01, 06F25-02, 03P92-25, 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-2171-2012%22
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