Z-0546-2024Class II

VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0

Name: Z-0546-2024 VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2023-10-10
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2023-10-10 / Open, Classified / root cause: software

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0 on 2023-10-10. FDA classified it as Class II and gives the reason as "During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen...". 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-0546-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-10
Posted: 2023-12-13
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: An URGENT PRODUCT CORRECTION NOTIFICATION letter dated 10/10/23 was sent to customers. REQUIRED ACTIONS " Review the Customer Actions for the Condition Codes described in this notification. " Acknowledge your understanding of this notification by completing the enclosed Confirmation of Receipt form no later than October 18, 2023. " Save this notification with your User Documentation or post this notification by each VITROS 3600/4600/5600/XT 3400/XT 7600 System until this issue is resolved. " If your laboratory has experienced the issue described in this notification and you have not already done so, please report the occurrence to your local Global Services Organization (Previously Ortho Care). Resolution QuidelOrtho is investigating root cause and will communicate again after root cause has been determined. A software update to address this issue is currently in development. Contact Information We apologize for any inconvenience this may cause your laboratory. If you have further questions, please contact our Global Services Organization at 1-800-421-3311.
Quantity in commerce: 51 units
Distribution: US Nationwide. Global Distribution.
Product codes and lots: Product Code: 6844458, UDI-DI: 10758750031986; Serial Numbers: J34500140 J34500113 J34500180 J34500114 J34500257 J34500116 J34500289 J34500117 J34500319 J34500123 J34500386 J34500128 J34500422 J34500129 J34500447 J34500130 J34500473 J34500139 J34500474 J34500190 J34500510 J34500261 J34500539 J34500269 J34500547 J34500271 J34500579 J34500292 J34500588 J34500301 J34500622 J34500337 J34500656 J34500356 J34500777 J34500363 J34500818 J34500515 J34500887 J34500520 J34500893 J34500536 J34500896 J34500582 J34500911 J34500609 J34500931 J34500628 J34500658 J34500711 J34500793

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0546-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0543-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-13
Z-0544-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-13
Z-0545-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-13
Z-0546-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-13
Z-0547-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-13

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)