i-STAT G3+ Cartridge; pH, pCO2, PO2; IVD Abbott Point of Care The test for PCO2, as part of the i-STAT System, is intended for use in the vitro quantification of carbon dioxide partial pressure in arterial, venous or capillary whole blood. PCO2 along with pH is used to assess acid-base balance.
Recall
- Recall Number
- Z-0930-2011
- Event Number
- 56403
- Firm
- Abbott Point of Care Inc.
- FEI Number
- 2245578
- Product Code
- CHL
- Status
- Terminated
- Root Cause
- Other
- Initiated
- August 3, 2010
- Posted
- January 20, 2011
- Terminated
- December 5, 2011
- Address
- 400 College Rd E, Princeton, NJ, 08540-6607
Description
i-STAT G3+ Cartridge; pH, pCO2, PO2; IVD Abbott Point of Care The test for PCO2, as part of the i-STAT System, is intended for use in the vitro quantification of carbon dioxide partial pressure in arterial, venous or capillary whole blood. PCO2 along with pH is used to assess acid-base balance.
Two cartridge lots were identified that may generate falsely elevated PCO2 results.
Abbott Point of Care Inc. sent an Urgent Recall Notice letter dated July 2010 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 cartridges from the identified lots and follow the instructions on the enclosed reply card to receive replacement cartridges. If cartridges were distributed from the lot numbers to another institution, a copy of the recall letter should be provided to them. For any questions regarding this recall contact Abbott-Point of Care Technical Support at 800-366-8020, Option 1.
Worldwide Distribution - USA including AL, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, and WY and the countries of Oman and Turkey.
55350 total cartridges