![]() ![]() 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. ![]() 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. We are committed to developing tests capable of putting invaluable answers in the hands of clinicians and caregivers around the world. 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. Our point-of-care diagnostics are focused on the world’s most critical health needs including cardiology, infectious disease, toxicology, traumatic brain injury, and more. 1 2 In the JammLite utility, select the i-STAT 300 Analyzer within the Instrument. 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. Abbott i-STAT 1 Manual Online: Updating Your I-Stat 1 Handheld. 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. Coagulation testing take up to 10 minutes to complete. 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 For i-STAT test cartridge information and intended use, refer to individual product pages or the cartridge information (CTI/IFU) in the i-STAT Support area.Ībbott - A Leader in Rapid Point-of-Care Diagnostics.Class 2 Device Recall iSTAT Level 2 Control Check with your local representative for availability in specific markets. Not all products are available in all regions. GDPR Statement | Declaration for California Compliance Law. Our newest instrument makes diagnostic testing easier than ever. Any person depicted in such photographs is a model. Photos displayed are for illustrative purposes only. ![]() Your use of this website and the information contained herein is subject to our Website Terms and Conditions and Privacy Policy. The products and information contained herewith may not be accessible in all countries, and Abbott takes no responsibility for such information which may not comply with local country legal process, regulation, registration and usage. ![]() This website is governed by applicable U.S. of control fluid that will be required to be run on the handheld during this QC cartridge schedule timeframe and click Update. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. The i-STAT Conversion Guide will help customers transition an existing testing. View and Download Abbott I-STAT 1 system manual online. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. ![]()
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