FDA Medical Device Recalls (openFDA)
Ortho Clinical Diagnostics: VITROS XT3400 Chemistry System, Product code 6844458
- Recall number
- Z-2878-2020
- Recalling firm
- Ortho Clinical Diagnostics
- Product
- VITROS XT3400 Chemistry System, Product code 6844458
- Status
- Terminated
- Initiated
- 2020-07-20
- Posted
- not on file
- Terminated
- 2023-12-18
- Reason
- 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.
- Root cause
- Process control
- Action
- The firm notified customers through Urgent Product Correction Notification letters on July 20, 2020. Customers were informed of the potential issue with incubator slot 18 of affected devices. Customers were provided with a table of the eight assays with biases which do not align with the assay's intended clinical use. Customers who had already been identified as experiencing this issue through their e-connected systems, or who did not have e-connected systems, received a letter stating that the recalling firm would be replacing the CM Rotor to resolve the issue. Customers who had e-connected systems but who had not yet been identified as experiencing this issue were informed that Ortho would continue to monitor their system for an increase in the frequency of condition codes related to slide misalignment. If impacted, those customers would also receive a replacement CM Rotor. Customer actions: " If you suspect an erroneous result has occurred or you observe an increase in the frequency of TH4-60J/TH4-63J condition codes, contact Ortho Care Technical Solutions Center. " Review the enclosed Assay Observed Bias sheet for VITROS Slides assays used by your laboratory. Discuss any concerns with your Laboratory Medical Director. " Complete the Confirmation of Receipt form and return to the firm " Post this notification by each VITROS XT 3400 and/or XT 7600 System in your facility or with the user documentation.
- Quantity
- pending
- Distribution
- 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.
- Lot, serial or model codes
- Serial numbers J34500122 J34500231
- 510(k) numbers
- ["K182063"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1000136573
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28