FDA Device recall Z-0716-2013
Abbott Point of Care i-Stat cTnI cartridge
- FDA Device
- Class II
- terminated
- Published 2013-01-30
On 2013-01-30 the FDA classified a Class II recall of Abbott Point of Care i-Stat cTnI cartridge by Abbott Point, citing APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0716-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-01 |
| Published | 2013-01-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Abbott Point |
| Distribution | n/a |
Product
Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to the relative risk of mortality.
Reason
APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack.
Identifiers
| code_info | List number 06F15-03, O6F15-04, 03P90-25, 600-9009-25 Lot number P12179 |
|---|
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-0716-2013%22
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