i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of
FDA device recall Z-2022-2011 · posted 2011-04-18 · Terminated
Recall details
- Recalling firm
- Abbott Point Of Care Inc.
- Reason for recall
- i-STAT CHEM 8+ cartridge may generate false results for sodium, chloride and hematocrit.
- Action taken
- The firm, Abbott Point of Care (APOC), sent an "Urgent Recall Notice" letter dated February 2011 with business reply cards attached via Fed Ex overnight to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of cartridges from the box numbers of identified lots; discontinue use as a precaution, if their cartridges are no longer traceable to a specific box; return all unused cartridges as instructed on the enclosed Business Reply Card; if they've provided another institution with the cartridges, provide the institution with a copy of this letter, and complete and return the business reply card to APOC. If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-336-8020, Option 1 or your Abbott Point of Care representative.
- Root cause
- Other
- Status
- Terminated
- Product code
- JGS
- Quantity affected
- 6575 cartirdges
- Distribution
- Nationwide distribution.
- Date initiated
- 2011-02-15
- Date posted
- 2011-04-18
- Date terminated
- 2012-07-10
- Location
- Princeton, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge (K053110) | I-Stat Corporation | 2006-01-13 |