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
This recall has been terminated (originally issued March 20, 2019).
- Company
- Ortho-Clinical Diagnostics
- Recall Initiated
- March 20, 2019
- Terminated
- December 8, 2020
- Recall Number
- Z-1364-2019
- Quantity
- 85 units: US=19;OUS=66
- Firm Location
- Rochester, NY
- Official Source
- View on FDA website ↗
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
Distribution
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
Lot / Code Info
Serial Number 76000108 thru current.
Root Cause
Software design
Action Taken
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.