Class 2 Device Recall Landuaer microStar

• Date Initiated by Firm: February 08, 2024
• Date Posted: March 21, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1349-2024
• Recall Event ID: 94043
• Product Classification: Instrument, quality-assurance, radiologic - Product Code LHO
• Product: microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059
• Code Information: All Lot/Serial Numbers:
• Recalling Firm/ Manufacturer: Landauer; 2 Science Rd; Glenwood IL 60425-1531
• For Additional Information Contact: Ms. Sheena Moore; 203-539-9647
• Manufacturer Reason for Recall: Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated this action to remove all reference to use of the microStar readers with the nanoDot or any otherbdosimeter for medical applications from the product s user manual and software and to remove microStar readers from customers who use them only for medical applications.
• FDA Determined Cause: No Marketing Application
• Action: LANDAUER issued an URGENT - Medical Device Recall - RESPONSE REQUIRED notice to its consignees via email on 02/08/2024. The notice explained the firm was divesting itself of its therapy physics businesses and initiated this action to remove all reference to use of the microStar readers with the nanoDot or any other dosimeter for medical applications from the product s user manual and software and to remove microStar readers from customers who use them only for medical applications. The actions to be taken by customer/user are as follows: If using the product for medical applications only: 1. Immediately discontinue use of microStar reader 2. Fill out Business Reply Form 3. Return affected product to Sedgwick, a third-party recall firm that is assisting Landauer with this action), in accordance with the instructions below. If using the product for non-medical applications only: 1. Fill out Business Reply Form 2. Update Software by logging into https://ftp.landauer.com/, using following credentials and follow the instructions to install the new software. Username: microstar6 Password: Hsdtduw3w7284*@ 3. Review the revised User Manual available at https://www.landauer.com/user-manuals. Please refer to the User Manual provided by this link before using the product; all older versions are obsolete. If using the product for medical and non-medical applications: 1. Immediately discontinue use of microStar reader for medical applications 2. Fill out Business Reply Form 3. Update Software by logging into https://ftp.landauer.com/, using following credentials and follow the instructions to install the new software. Username: microstar6 Password: Hsdtduw3w7284*@ 4. Review the revised User Manual available at https://www.landauer.com/user-manuals. Please refer to the User Manual provided by this link before using the product; all older versions are obsolete. If using the product for medical applications only, uninstall the microStar software from the laptop and discard
• Quantity in Commerce: 975 units
• Distribution: Worldwide distribution - United States Nationwide and the countries of Argentina, Australia, Brazil, Canada, China, France, India, Japan, Jordan, Malaysia, Mexico, Pakistan, Peru, Philippines, Rep of Korea, Singapore, Sweden, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, Venezuela, Viet Nam.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. 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. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.