VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest
FDA Recall Z-1364-2019 · Posted None
Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeJJE
Date Initiated2019-03-20
Date Terminated2020-12-08
Product Quantity85 units: US=19;OUS=66
Reason for Recall
Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported
Firm Action
Ortho Clinical Diagnostics issued on 20 March 2019, a customer letter via FedEx overnight courier and/ or ORTHO PLUS e-Communications and and/or US Postal Service Priority Mail (for PO Boxes only) customers who were shipped affected VITROS XT 7600 Systems. Software Version 3.4.2 (MOD 4) will be provided for download or DVD format. Contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of AZ, CA, IL, OH, FL, TX, MI Foreign: Australia, Belgium, Chile, India, Italy, Japan, South Korea, Spain, Canada,, Phillippines
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.