Z-1364-2019 Class II Terminated
FDA device recall Z-1364-2019 was initiated by Ortho-Clinical Diagnostics on March 20, 2019 and is designated Class II. 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 The recall status is terminated (terminated December 8, 2020). Affected quantity: 85 units: US=19;OUS=66.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2019
- Initiation Date
- March 20, 2019
- Termination Date
- December 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 85 units: US=19;OUS=66
Product Description
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
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 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
Code Information
Serial Number 76000108 thru current.