VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
FDA device recall Z-1231-2024 · posted 2024-03-01 · Open, Classified
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- JJE
- Quantity affected
- 91 US; 94 OUS
- Distribution
- 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,
- Date initiated
- 2024-01-26
- Date posted
- 2024-03-01
- Location
- Rochester, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM (K081543) | Ortho-Clinical Diagnostics, Inc. | 2008-10-23 |