January 21, 2025

Jan

FDA Warning Letter: Lacking Pre-Market Clearance

January 21, 2025Allison PateNews

WARNING LETTER Robbins Instruments, LLC was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 687984 2003 Edwards Street Houston, TX 77007 United States Dates: March 27 through May 31, 2024 Inspection Issue(s): The report states that, “FDA has learned that your firm is marketing the Dermo-Jet Needleless...

Jan

FDA Recall: Software Error MAy Not Notify Users of Expiration Date

January 21, 2025Allison PateNews

Company: Ortho-Clinical Diagnostics, INC. Date of Enforcement Report: 1/21/2025 Class II PRODUCT Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (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 Recall...

FDA Warning Letter: Lacking Pre-Market Clearance

FDA Recall: Software Error MAy Not Notify Users of Expiration Date

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FDA Warning Letter: Lacking Pre-Market Clearance

FDA Recall: Software Error MAy Not Notify Users of Expiration Date

SoftwareCPR Training Courses:

Subscription Services

Corporate Office