![]() ![]() 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. Locate cartridge type and lot prefix letter WITHIN the value sheet that corresponds with your cartridge. 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. Locate and select the Control/Calibration Verification lot and type below that corresponds with your lot number. 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. 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. GEM Premier ChemSTAT is not available in all countries.Class 2 Device Recall iSTAT CHEM 8 CartridgeĮlectrode, ion specific, sodium - Product Code JGS ** Two eGFR results are provided by the analyzer if the Crea result, age, gender and ethnicity are available: eGFR AA (CKD-EPI) for African Americans (AA) and eGFR (CKD-EPI) for non-AA.Ĭrea (Creatinine), AG (Anion Gap), HCO 3 (Bicarbonate), BUN/Crea (BUN/Creatinine ratio) BEecf (Bace Excess of Extracellular Fluid ), BE(B) (Base Excess of Blood ), tHb(c) (Calculated Total Hemoglobin), Ca + + (7.4) (Ca ++ normalized to pH 7.4), Osm (Osmolality), eGFR (estimated Glomerular Filtration Rate), MDRD (Modification of Diet in Renal Disease), CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration) * Two eGFR results are provided by the analyzer if the Crea result, age, gender and ethnicity are available: eGFR AA (MDRD) for African Americans (AA) and eGFR (MDRD for non-AA. ![]()
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