Recall Z-1006-2025
Ortho-Clinical Diagnostics, INc. · initiated December 19, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot Code: VITROS XT 7600 Integrated System Product Code: 6844461 (New) UDI: 10758750012343 VITROS XT 7600 System (Certified) Product Code: 6272222 UDI: 10758750012343 Lot Code: VITROS XT 7600 Integrated System Product Code: 6904003 (China) UDI: 10758750035809 Range of installed serial numbers:76000001-76002199 Manufacture date range: July 2018 to present Distribution date range; July 2018 to present Total systems currently installed in the US: 994 Total systems currently installed outside the US: 899 Note1: The catalogue number 6844461 is used to denote the VITROS XT 7600 Integrated System. Catalogue number 6272222 is used to denote VITROS XT 7600 System Certified. A VITROS XT 7600 Integrated System maintains its original serial number through the certification process. Therefore, the manufacturing and distribution information for the two catalogue numbers will be combined. Note2: When manufactured the system s serial numbers are sequential, but not all analyzers are released for distribution and therefore not installed. The range of serial numbers provided includes the identified minimum and maximum in serial numbers associated with all currently installed systems. Therefore…
Reason for recall
The VITROS XT 7600 Integrated 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.
FDA-determined cause: Software Design Change
Action taken
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 Global Services Organization at 1-800-421-3311. To report adverse events, contact your local Global Services Organization. Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program: www.fda.gov/medwatch/report.htm, 1-800-332-1088.
Details
- Recall number
- Z-1006-2025
- Initiated
- December 19, 2024
- Posted by FDA
- January 21, 2025
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 1,893 units (994 US, 899 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.
- Recalling firm
- Ortho-Clinical Diagnostics, INc., Rochester, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1005-2025 Class II | Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number:…The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal… | 12/19/2024Open, Classified |
| Z-1007-2025 Class II | Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog…The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if the Signal… | 12/19/2024Open, Classified |