FDA Medical Device Recalls (openFDA)
Abbott Point of Care Canada Limited: 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.
- Recall number
- Z-0716-2013
- Recalling firm
- Abbott Point of Care Canada Limited
- 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.
- Status
- Terminated
- Initiated
- 2012-11-01
- Posted
- 2013-01-24
- Terminated
- 2013-06-14
- 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.
- Root cause
- Error in labeling
- Action
- APOC sent an "IMPORTANT PRODUCT INFORMATION" letter dated October 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Abbott Point Of Care Technical Support at 800-366-8020, Option 1 or your Abbott Point Of Care representative for questions regarding this information.
- Quantity
- 560 boxes (25 cartridges in each box)
- Distribution
- Worldwide Distribution.
- Lot, serial or model codes
- List number 06F15-03, O6F15-04, 03P90-25, 600-9009-25 Lot number P12179
- 510(k) numbers
- ["K031739"]
- PMA numbers
- not on file
- Product code
- MMI
- Firm FEI
- 3005643513
- Firm city
- Nepean
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28