Recall Z-0716-2013
Abbott Point of Care Canada Limited · initiated November 1, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: List number 06F15-03, O6F15-04, 03P90-25, 600-9009-25 Lot number P12179
Reason for recall
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-determined cause: Error in labeling
Action taken
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.
Details
- Recall number
- Z-0716-2013
- Initiated
- November 1, 2012
- Posted by FDA
- January 24, 2013
- Terminated
- June 14, 2013
- Product code
- MMI – Immunoassay Method, Troponin Subunit
- Quantity
- 560 boxes (25 cartridges in each box)
- Distribution
- Worldwide Distribution.
- Recalling firm
- Abbott Point of Care Canada Limited, Nepean