VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog Number 6802915, Unique Device Identifier No. 10758750007110; IVD.

Recall Insight

This FDA Devices action (record #Z-1914-2016) was formally reported on June 15, 2016, with the manufacturer initiating the action on April 6, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Ortho-Clinical Diagnostics is listed as the recalling firm, operating out of Rochester, NY. Federal records indicate VITROS 5600: US: 1161 units, Foreign: 1063 units; VITROS 5600 Refurbished: US: 19 units, Foreign: 38 units units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated re… Distribution data in the federal record shows the product reached: Nationwide, Puerto Rico and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezu…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.