Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. The oxidation of sarcosine produces hydrogen peroxide. Creatinine is hydrolyzed to sarcosine through a two step process. CREATININE (Crea): This parameter is measured amperometrically. If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 80, Option 1 or your Abbott Point of Care representative.ġ A record in this database is created when a firm initiates a correction or removal action. Uses the CG4+ i-stat cartridge CCLS only as a backup method for the Chemistry analyzer. 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. The letter described the product, problem and actions to be 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. I-STAT CHEM 8+ cartridge may generate false results for sodium, chloride and hematocrit. This test panel is also used to assess hypertension and hypokalemia.ĥ10 K053110 Lot # C10247 boxes 0532 through 0593 The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. Useful for monitoring a variety of conditions. I-STAT CHEM 8+ Cartridge, List Number 03P91-25 510 K053110 Date: 2 i-STAT G Cartridge NAME i-STAT G Cartridge REF 03P83-25 INTENDED USE The test for glucose, as part of the i-STAT System, is intended for use in the in vitro quantification of glucose in arterial, venous, or capillary whole blood. Class 2 Device Recall iSTAT CHEM 8 CartridgeĮlectrode, ion specific, sodium - Product Code JGS Diagnostic Plans & Panels Testing Protocols & Interpretations How To Send.
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