Z-1364-2019Class II

VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW

Name: Z-1364-2019 VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW
Creator: Ortho-Clinical Diagnostics
Published: 2019-03-20
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2019-03-20 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600... on 2019-03-20. FDA classified it as Class II and gives the reason as "Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1364-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-20
Posted: 2019-05-20
Terminated: 2020-12-08
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported
Root cause tag: software
FDA root cause: Software design
Action: Ortho Clinical Diagnostics issued on 20 March 2019, a customer letter via FedEx overnight courier and/ or ORTHO PLUS e-Communications and and/or US Postal Service Priority Mail (for PO Boxes only) customers who were shipped affected VITROS XT 7600 Systems. Software Version 3.4.2 (MOD 4) will be provided for download or DVD format. Contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
Quantity in commerce: 85 units: US=19;OUS=66
Distribution: Worldwide Distribution - US Nationwide in the states of AZ, CA, IL, OH, FL, TX, MI Foreign: Australia, Belgium, Chile, India, Italy, Japan, South Korea, Spain, Canada,, Phillippines
Product codes and lots: Serial Number 76000108 thru current.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1364-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1364-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-20

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)