#Istat chem 8 code#

Perform testing immediately if collected in syringe. Specimen Type: Venous or arterial whole bloodContainer/Tube: Green top (lithium or sodium heparin)-Syringe is also acceptable.Specimen Volume:Full tubeCollection Instructions:1.

#Istat chem 8 code#

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. Specimen must be tested within 10 minutes of draw. 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. 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. Provides the ability to test small or ill animals such as an anemic puppy or the fractious cat. Saves counter space and money while improving in-house testing capability. I-STAT CHEM 8+ cartridge may generate false results for sodium, chloride and hematocrit. Acid-base, blood gas, electrolyte, chemistry, and hematology testing with one platform. Action 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. This test panel is also used to assess hypertension and hypokalemia.ĥ10 K053110 Lot # C10247 boxes 0532 through 0593 I-stat chem 8+ cartridge may generate false results for sodium, chloride and hematocrit. 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 test cartridges deliver lab-quality results without having to leave the patient's side.Class 2 Device Recall iSTAT CHEM 8 CartridgeĮlectrode, ion specific, sodium - Product Code JGS I-STAT System single-use test cartridges are designed to help reduce the problems multi-use systems face with poor quality and/or clotted samples. Testing Procedures for i-STAT Chemistry Cartridges These testing procedures are for use with the following CLIA-waived i-STAT cartridges: CHEM8+, 6+, EC4+, E3+, Crea, and G.

Consolidating analytes on one cartridge.Minimising the risk of sample clotting before or during testing.

Eliminating re-sticks due to delays with multi-use analyzers.The i-STAT System can significantly reduce blood requirements by: To perform a test, 2 to 3 drops of blood are applied to a cartridge, which is then inserted into the i-STAT handheld. The i-STAT System offers the most comprehensive range of clinical tests in a single point-of-care platform, allowing clinicians to access the time-sensitive diagnostic information they need, when and where they need it. Requiring just two to three drops of blood, Abbott i-STAT test cartridges deliver lab-quality results without having to leave the patient's side.The i-STAT test menu covers a broad range of clinical tests, from cardiac markers to coagulation. I-stat chem 8+ cartridge may generate false results for sodium, chloride and hematocrit.