Using i-STAT ® Analyzer Customization Features to Result Calibration Modes for the i-STAT 1 Analyzer. Hematocrit on the i-STAT System.ĪCT Test Result Options: Prewarmed vs. Receive Data from a Philips Clinical Data Server. Installation Guide for the Central Data Station to Hematocrit Determination in the i-STAT SystemĪnd Comparison to Other Methods. Prothrombin Time PT/INR.Ĭardiac Troponin I.Ĭreatine Kinase MB / CK-MB.ī-Type Natriuretic Peptide/BNP.Īnalyzer Coded Messages.
#Istat clew manual#
In the event that your System Manual does not contain the current configuration, it is recommended that you contact your i-STAT support provider.Īs of April 2008, your i-STAT ®1 System Manual should be configured with the contents as listed below and in the order shown.Ĭover Sheet. Please ensure that the contents of your System Manual are complete and up to date.
#Istat clew windows#
Windows is a registered trademark of Microsoft Corporation. Precision and PCx are trademarks of Abbott Laboratories. MediSense is a registered trademark of Abbott Laboratories. I-STAT is a registered trademark of Abbott Laboratories. Symbol Technologies Corporation is the owner of US Patent Nos. 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.
#Istat clew update#
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.
#Istat clew code#
Multi- analyte controls, all kinds (assayed) - Product Code JJY Class 2 Device Recall iSTAT Level 2 Control
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