FDA Device recall Z-2170-2012
i-Stat BNP 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 BNP 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-2170-2012 |
| 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 BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.
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 06F30-01, 06F30-02, 03P93-25, 600-9010-25 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-2170-2012%22
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