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.
FDA Recall Z-0929-2011 · Posted 2011-01-20
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Recalling FirmAbbott Point of Care Inc.
Recall StatusTerminated
Product CodeCHL
Date Initiated2010-08-03
Date Terminated2011-12-05
Product Quantity55350 total cartridges
Reason for Recall
Two cartridge lots were identified that may generate falsely elevated PCO2 results.
Firm Action
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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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