Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for
FDA device recall Z-0716-2013 · posted 2013-01-24 · Terminated
Recall details
- Recalling firm
- Abbott Point of Care Canada Limited
- 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.
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MMI
- Quantity affected
- 560 boxes (25 cartridges in each box)
- Distribution
- Worldwide Distribution.
- Date initiated
- 2012-11-01
- Date posted
- 2013-01-24
- Date terminated
- 2013-06-14
- Location
- Nepean, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| I-STAT CARDIAC TROPONIN (CTNI) TEST (K031739) | I-Stat Corporation | 2003-09-02 |