Reported Jan 30, 2013 · Terminated

Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test…

Abbott Point of Care Canada Limited

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Abbott Point of Care Canada Limited · 185 Corkstown Road · Nepean, N/A · N/A

Is this the product you have?

  • 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.
Lot codes and dates
    • List number 06F15-03
    • O6F15-04
    • 03P90-25
    • 600-9009-25 Lot number P12179
Amount recalled
560 boxes (25 cartridges in each box)

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 14, 2013 · Data as of Sep 19, 6:14 PM UTC

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