Z-2879-2020 Class II Terminated
FDA device recall Z-2879-2020 was initiated by Ortho Clinical Diagnostics on July 20, 2020 and is designated Class II. Reason for recall: When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results. The recall status is terminated (terminated December 18, 2023). Affected quantity: pending.
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2020
- Initiation Date
- July 20, 2020
- Termination Date
- December 18, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- pending
Product Description
VITROS XT7600 Integrated System, Product code 6844461
Reason for Recall
When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
Code Information
Serial numbers J76000050 - 76000566