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Vitros® 4600, 5600 and 7600 systems
Official notice
5 Jun 2025
Last checked
5 Jun 2025
An official Health Canada notice concerns Vitros® 4600, 5600 and 7600 systems. The VITROS® system software is designed to apply a "reagent expired" (re) code to results if the 'use expired reagents' option has been enabled, and an expired reagent is used. If 'use expired reagents' has not been enabled, the VITROS® system software is expected to report a "no result" and apply an "insufficient inventory (ii)" code when attempting to process samples using expired reagents, including diluents. QuidelOrtho received a customer complaint stating that their VITROS® system had applied an re code to results despite the 'use expired reagents' option not enabled on their VITROS® system. QuidelOrtho investigated the complaint and determined that a software anomaly exists in the VITROS® system software, affecting all available versions. Despite the 'use expired reagents' option not enabled, if a VITROS® diluent pack lot is manually loaded on VITROS® 4600, 5600, and XT 7600 systems with the shelf expiration date left blank, the VITROS® system will flag the pack as expired but report results, applying an re code to the results. Please note that the anomaly will allow the VITROS® system to report results using VITROS® diluent packs which have not reached the shelf expiration date and expired VITROS® diluent packs (as printed on the product labeling), if the VITROS® diluent pack was manually loaded with the shelf expiration date left blank. Recall start date: May 22, 2025 Published 2025-06-05.
What to do now
Contact the manufacturer if you require additional information.
Recall number
77563
Official notice
2025-06-05
The hazard
The hazard
The VITROS® system software is designed to apply a "reagent expired" (re) code to results if the 'use expired reagents' option has been enabled, and an expired reagent is used. If 'use expired reagents' has not been enabled, the VITROS® system software is expected to report a "no result" and apply an "insufficient inventory (ii)" code when attempting to process samples using expired reagents, including diluents. QuidelOrtho received a customer complaint stating that their VITROS® system had applied an re code to results despite the 'use expired reagents' option not enabled on their VITROS® system. QuidelOrtho investigated the complaint and determined that a software anomaly exists in the VITROS® system software, affecting all available versions. Despite the 'use expired reagents' option not enabled, if a VITROS® diluent pack lot is manually loaded on VITROS® 4600, 5600, and XT 7600 systems with the shelf expiration date left blank, the VITROS® system will flag the pack as expired but report results, applying an re code to the results. Please note that the anomaly will allow the VITROS® system to report results using VITROS® diluent packs which have not reached the shelf expiration date and expired VITROS® diluent packs (as printed on the product labeling), if the VITROS® diluent pack was manually loaded with the shelf expiration date left blank. Recall start date: May 22, 2025
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
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Brand: Ortho-clinical Diagnostics, Vitros® 4600 5600 And 7600.
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Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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