FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics, Inc.: VITROS XT 3400 Chemistry System, Catalog No. 6844458
- Recall number
- Z-1232-2024
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Product
- VITROS XT 3400 Chemistry System, Catalog No. 6844458
- Status
- Open, Classified
- Initiated
- 2024-01-26
- Posted
- 2024-03-01
- Terminated
- not on file
- Reason
- A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
- Root cause
- Software Design Change
- Action
- On January 26, 2024, the firm issued a customer letter to all customers who have V3.8.0 or V3.8.1 installed on their VITROS Analyzer. Customers were informed of the issue and instructed to follow the instructions when using the VITROS System onboard QC package to use the configurable Westgard Rules. The software will be updated to mitigate this issue within the VITROS Software QC feature. The estimated availability is 2Q2024. If you have further questions, please contact Global Services Organization at 1-800-421-3311.
- Quantity
- 25 US; 26 OUS
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
- Lot, serial or model codes
- VITROS System Software Versions 3.8.0 or 3.8.1 UDI-DI 10758750031986 Serial Numbers: US: J34500140 J34500180 J34500257 J34500289 J34500319 J34500386 J34500422 J34500447 J34500473 J34500474 J34500510 J34500539 J34500547 J34500579 J34500588 J34500622 J34500656 J34500777 J34500818 J34500861 J34500887 J34500893 J34500896 J34500911 J34500931 OUS: J34500123 J34500128 J34500129 J34500130 J34500190 J34500261 J34500269 J34500271 J34500292 J34500301 J34500337 J34500356 J34500363 J34500515 J34500520 J34500536 J34500582 J34500609 J34500628 J34500658 J34500711 J34500793 J34500802 J34500940 J34500960 J34500962
- 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