![]() Results: The standard deviation for the spun samples was 6.42% while the standard deviation for the i-STAT® samples was 6.79%. ![]() All analyses were performed by certified operators. The same sample was used to fill the cartridge for the i-STAT® and two centrifuge tubes for the spun hematocrit. ![]() Methods: After receiving IRB approval, samples from 50 consented patients, clinically determined to likely require intraoperative hemoglobin values, were obtained in a single 3cc heparinized syringe and transported to a laboratory located within the operating rooms. In August of 2009, we evaluated the accuracy of the i-STAT® by comparing its results with those obtained by the spun hematocrit method. The company advised that the hematocrit coefficient had been raised, yielding a 1% PCV increase for the hematocrit value and approximately a 0.3g/dL rise for a hemoglobin result. Introduction: Portable blood gas analyzers using the conductivity method (e.g., i-STAT®) provide ease and convenience in the dynamic setting of the operating room, but are they accurate? In October of 2007, a software change was issued for the i-STAT® portable handheld analyzer (CLEW A14 Abbott Point of Care, East Windsor, NJ). Susan Ourada, B.A., Allan Klock, M.D., Ronald Thisted, Ph.D., Mark Nunnally, M.D., Thomas Cutter, M.D.Īnesthesia and Critical Care, University of Chicago, Chicago, Illinois ![]() 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.Comparing the Accuracy of i-STAT® with a Spun Hematocrit: A Prospective, Case-Control Study 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. Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of Argentina, Austria, Belgium, Bolivia, Brazil, Chile, China, Columbia, El Salvador, France, Georgia Republic, Germany, Hong Kong, Israel, Italy, Kuwait, Mexico, Netherlands, New Zealand, Panama, Paraquay, Peru, Poland, South Africa, Sweden, Switzerland, Taiwan, Turkey, UAE, UK, Uruquay, and Yemen.ġ A record in this database is created when a firm initiates a correction or removal action. Questions or comments are to be directed to Abbott Point of Care Technical Support at 80, Option 1. The Business Reply card is to be completed and returned to Abbott. If the control materials, discs or value sheets have been forwarded to another facility, a copy of the letter was to be sent to them. ASLO, if they have a disc with the Value sheets on it, it is to be replaced with the updated disc and the original discarded. Customers were asked to replace all copies of the value sheets with the ones provided in the letter. The letter identified the product, the problem, and the action to be taken by the customer. Three i-STAT Level 2 Control Value Assignment Sheets and the i-STAT CLEW A20 Software System Manual Update CD contain the incorrect range for pCO2, BUN and Glucose for the i-STAT EC8+, 6+, EC4+, E3 and G cartridge types.Ībbott Point of Care Inc., sent an URGENT RECALL NOTICE to all affected customers on. I-STAT Level 2 Control Value Assignment SheetsĪbbott List Number: 06F13-01 Lot number B09342 - CLEW A20 artwork 726778-01A.pdf Lot number B09154 - CLEW A20 artwork 726774-01A.pdf Lot number B09342 - CLEW A18 artwork 726668-01A.pdf. Expiration: 11/2010. Abbott List Number: 025715, CLEW A20 Compact Disc containing value assignment sheets. Multi- analyte controls, all kinds (assayed) - Product Code JJY Class 2 Device Recall iSTAT Level 2 Control
0 Comments
Leave a Reply. |