i-STAT cTnI cartridges recallZ-2237-2012 · Abbott Point Of Care Inc. · initiated Mar 7, 2012
Class II Terminated All recalls posted in August 2012
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 Inc. 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
Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit incorrectly elevated cardiac troponin I results. This recall was expanded on July 19 2012 to include additional information regarding user documentation.
FDA root cause category: Device Design
What the company is doing
Abbott Point of Care (APOC) sent an Urgent Recall Notice letters, via Fed Ex on March 07, 2012 to all affected customers. APOC sent an important product information update on July 19, 2012 to all of their affected customers. The letter identified the affected product, problem and actions to be taken. Customers are asked to review the information included as it may pertain to their cartridges. Customers were instructed that if the affected product have been forwarded to another facility, provide a copy of this letter to them. For additional information, contact APOC at 800-366-8020 option 1 or your Abbott Point of Care representative.
Recall details
- Recall number
- Z-2237-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 7, 2012
- Posted by the FDA
- Aug 22, 2012
- Recalling firm
- Abbott Point Of Care Inc.
- Quantity
- 7,057675 cartridges US; 772,400 cartridges OUS
- Product code
- MMI
- FDA submissions
- K031739
- Distribution
- Worldwide Distribution - US Nationwide, International
Product description
i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
Code information (models, lots, serial numbers)
510(K)K031739 List Number 06F15-03, 06F15-04, 03P90-25, 600-9009-25 All lots
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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