Z-1232-2024Class II

VITROS XT 3400 Chemistry System, Catalog No. 6844458

Name: Z-1232-2024 VITROS XT 3400 Chemistry System, Catalog No. 6844458
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2024-01-26
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2024-01-26 / Open, Classified / root cause: software

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS XT 3400 Chemistry System, Catalog No. 6844458 on 2024-01-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1232-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-26
Posted: 2024-03-01
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS XT 3400 Chemistry System, Catalog No. 6844458
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: 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 tag: software
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1232-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1229-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1230-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1231-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1232-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1233-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01

Product code JJE

K182063Class IIVITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated SystemOrtho-Clinical Diagnostics, Inc. / cleared 2018-10-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)