Z-1222-2019 Class II Terminated
FDA device recall Z-1222-2019 was initiated by Ortho-Clinical Diagnostics on March 11, 2019 and is designated Class II. Reason for recall: One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to incorrect results being reported without an error … The recall status is terminated (terminated December 7, 2020). Affected quantity: 80.
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2019
- Initiation Date
- March 11, 2019
- Termination Date
- December 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80
Product Description
VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents, and VITROS Immunodiagnostic Products Reagents
Reason for Recall
One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to incorrect results being reported without an error code to alert the user.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of: AZ, CA, FL, IL, OH, TX, and VA. The products were distributed to the following foreign countries: Australia, Belgium, Canada, Chile, Columbia, France, India, Italy, Japan, Portugal, Singapore, Spain, United Kingdom
Code Information
Systems Running Software Version 3.4 & 3.4.1