i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.
Recall
- Recall Number
- Z-1306-2014
- Event Number
- 67513
- Firm
- Abbott Point Of Care Inc.
- FEI Number
- 2245578
- Product Code
- CHL
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- January 1, 2014
- Posted
- March 27, 2014
- Terminated
- October 20, 2014
- Address
- 400 College Rd E, Princeton, NJ, 08540-6607
Description
i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.
Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results.
APOC sent an Urgent Recall Notice dated January 2014 via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product and provide a copy of this letter to any institution that was forwarded the affected product. All unused cartridges will be credited and are to be returned as instructed on the enclosed Business Reply Card. To ensure continuity of supply at their facility, customers were instructed to follow their standard process to place an order or call Customer Sedrvice at 1-800-323-9100, Option #2, then Option #9). Customers with questions were instructed to contact Abbott Point of Care Technical Support at 1-800-366-8020, Option 1 of their Abbott Point of Care representative. For questions regarding this recall call 800-323-9100.
Worldwide Distribution - USA (nationwide) and Internationally to Canada.
48, 450 US, 1400 OUS (49,850 catridges)