Recall Z-1364-2019
Ortho-Clinical Diagnostics · initiated March 20, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Serial Number 76000108 thru current.
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
FDA-determined 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.
Details
- Recall number
- Z-1364-2019
- Initiated
- March 20, 2019
- Terminated
- December 8, 2020
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 85 units: US=19;OUS=66
- 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
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY