Recall Z-1007-2025 · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Ortho-Clinical Diagnostics, INc.

Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: no, not a component

Date	Jan 21, 2025 (initiated Dec 19, 2024)
Status	Open, Classified
Reason	The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.
Root cause	Software Design Change
Action	On December 19, 2024 URGENT PRODUCT CORRECTION NOTIFICATION letters were sent to customers. REQUIRED ACTION " Do not use expired Signal Reagent packs. See the Questions & Answers section for more details. " Complete the enclosed Confirmation of Receipt form no later than December 31, 2024. " Save this notification with your User Documentation or post this notification by each VITROS 3600/5600/XT 7600 System in your laboratory until the issue has been resolved. Contact Information We apologize for the inconvenience this will cause your laboratory. If you have further questions, please contact G
Quantity	981 units (99 US, 882 OUS)
Distribution	Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.
FDA record	Open on fda.gov

510(k) clearances named in this recall

K083173

VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM
Ortho-Clinical Diagnostics, Dec 22, 2008