Z-1675-2022Class II

VITROS XT 3400 Chemistry System with Version 3.7.2 and below

Name: Z-1675-2022 VITROS XT 3400 Chemistry System with Version 3.7.2 and below
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2022-07-19
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2022-07-19 / Open, Classified

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458 on 2022-07-19. FDA classified it as Class II and gives the reason as "Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1675-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-19
Posted: 2022-09-02
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
FDA root cause: Under Investigation by firm
Action: Ortho CLinical issued Urgent Medical Device Correction letter on 19 July 2022 to consignees who received a VITROS XT3400 or a VITROS XT7600 System notified via (CL2020-176) of the issue and instructed to: " If your VITROS XT 3400 and/or VITROS XT 7600 Systems require a system shutdown, routine Quality Control processing for MicroSlide assays must be performed per your laboratory procedure, prior to processing patient samples, to determine if the anomaly has occurred. " If QC results are outside your established ranges, Ortho recommends performing a second system shutdown and re-processing QC fluids for those assays that were outside your established ranges. If QC results are still outside established ranges following a second system shutdown, contact Ortho Care" Technical Solutions Center for guidance. " Ortho recommends using the same vial of QC fluids (where possible) throughout these steps to determine if the anomaly has occurred. Refer to the control storage and stability documentation for fluid stability guidelines once opened or reconstituted. " Post this notification by each VITROS XT 3400 and/or XT 7600 System until this issue is resolved. Ortho is currently investigating this issue; a follow-up communication will be released once our investigation is complete. " Complete the enclosed Confirmation of Receipt no later than July 26, 2022. If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
Quantity in commerce: 506 units
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Brazil, Canada L3R 4G5 , Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.
Product codes and lots: UDI-DI: 10758750031986 Systems start with 3400XXXX where XXXX is unique for each analyzer

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1675-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1675-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-02
Z-1676-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-02

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)