VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
FDA Recall Z-1230-2024 · Posted 2024-03-01
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Recalling FirmOrtho-Clinical Diagnostics, Inc.
Recall StatusOpen, Classified
Product CodeJJE
Date Initiated2024-01-26
Product Quantity15 US; 43 OUS
Reason for Recall
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
Firm Action
On January 26, 2024, the firm issued a customer letter to all customers who have V3.8.0 or V3.8.1 installed on their VITROS Analyzer. Customers were informed of the issue and instructed to follow the instructions when using the VITROS System onboard QC package to use the configurable Westgard Rules.
The software will be updated to mitigate this issue within the VITROS Software QC feature. The estimated availability is 2Q2024.
If you have further questions, please contact Global Services Organization at 1-800-421-3311.
Root Cause
Software Design Change
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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