Recall Z-1222-2019
Ortho-Clinical Diagnostics · initiated March 11, 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, 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
Codes / lots: Systems Running Software Version 3.4 & 3.4.1
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.
FDA-determined cause: Software design
Action taken
Urgent Product Correction Notification letters dated 3/11/19 were sent to customers.
Details
- Recall number
- Z-1222-2019
- Initiated
- March 11, 2019
- Terminated
- December 7, 2020
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 80
- Distribution
- 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
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY