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. types): The UNFOLDER Emerald Series Cartridge System implantation EmeraldC (1. Martin, and Turks & Caicos.ġ A record in this database is created when a firm initiates a correction or removal action. Firm PP: Abbott Medical Optics / NSX: AMO Manufacturing Puerto Rico / US. Screw-style insertion provides predictable delivery from start to finish. Cartridge lock allows for secure loading in the correct position. ![]() Y-tip plunger rod assists in lens manipulation. Worldwide distribution: USA including: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, and WV and countries including: Australia, Brazil, Canada, Columbia, Dominican Republic, Germany, Puerto Rico, Singapore, South Korea, St. With its unique design, the UNFOLDER® Platinum Series handpiece provides precise, controlled delivery. Abbott informed the customers that they would receive a mandatory software update and were instructed to install the CELL-DYN Emerald according to the attached instructions, and to complete and return the Customer Reply form via fax to 1-80 or email to you have any questions or would like to discuss in more detail, contact Director Quality Assurance and Regulatory Affairs Abbott Hematology at 40. AMO Opthalmic Unfolder System Emerald Series Handpiece EMERALDXL. The customers were instructed to perform the following steps, noted in the letter, to print and verify their gain setting. New Abbott Medical Optics EMERALDXL Handpiece AMO The Unfolder Acrylic Optiedge. The letters described the product, problem and actions to be taken. The firm, Abbott, sent two "Product Correction" letters one dated March 23,2010 and a follow-up letter dated July 1, 2010, via express mail to all its consignees/customers. ![]() esgrima alcobendas, Street magic tv show, Keeping an eye on art, Pull dozer for sale. There is the potential for impact to product performance. Mirage tower emerald fossils, Coach f13102, 8 gauge wire lowes. The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.Ībbott has determined that gain settings for the non-standard specimen types may not match the gain settings for the standard specimen type. Class 2 Device Recall CELLDYN Emerald Hematology Analyzer SystemĬounter, differential cell - Product Code GKZĪbbott brand CELL-DYN Emerald Hematology Analyzer System List Numbers: 09H39-01 The product is manufactured in France for Abbott Diagnostics Division of Abbott Laboratories, Abbott Park, IL
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