i-STAT CG8+ Cartridge; pH, pCO2, PO2, NA, K, iCa, Glu, Hct; 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.
This recall has been terminated (originally issued January 20, 2011).
- Company
- Abbott Point Of Care Inc.
- Recall Initiated
- August 3, 2010
- Posted
- January 20, 2011
- Terminated
- December 5, 2011
- Recall Number
- Z-0929-2011
- Quantity
- 55350 total cartridges
- Firm Location
- Princeton, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Two cartridge lots were identified that may generate falsely elevated PCO2 results.
Distribution
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.
Lot / Code Info
List number 03M86-01, 03M86-02, lot number T10036A
Root Cause
Other
Action Taken
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.