Abbott Point of Care i-Stat cTnI cartridge recallZ-0716-2013 · Abbott Point of Care Canada Limited · initiated Nov 1, 2012
Class II Terminated All recalls posted in January 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Point of Care Canada Limited or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack.
FDA root cause category: Error in labeling
What the company is doing
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.
Recall details
- Recall number
- Z-0716-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 1, 2012
- Posted by the FDA
- Jan 24, 2013
- Recalling firm
- Abbott Point of Care Canada Limited
- Quantity
- 560 boxes (25 cartridges in each box)
- Product code
- MMI
- FDA submissions
- K031739
- Distribution
- Worldwide Distribution.
Product description
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.
Code information (models, lots, serial numbers)
List number 06F15-03, O6F15-04, 03P90-25, 600-9009-25 Lot number P12179
Other devices under the same FDA submission
1 device cleared under K031739 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- i-STAT 03P90-25Abbott Point Of Care Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT474 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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