Z-1222-2019Class II

VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658

Name: Z-1222-2019 VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658
Creator: Ortho-Clinical Diagnostics
Published: 2019-03-11
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2019-03-11 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in... on 2019-03-11. FDA classified it as Class II and gives the reason as "One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to incorrect results being reported without an error code to alert the...". 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-1222-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-11
Posted: 2019-04-25
Terminated: 2020-12-07
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents, and VITROS Immunodiagnostic Products Reagents
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to incorrect results being reported without an error code to alert the user.
Root cause tag: software
FDA root cause: Software design
Action: Urgent Product Correction Notification letters dated 3/11/19 were sent to customers.
Quantity in commerce: 80
Distribution: Worldwide Distribution - US Nationwide in the states of: AZ, CA, FL, IL, OH, TX, and VA. The products were distributed to the following foreign countries: Australia, Belgium, Canada, Chile, Columbia, France, India, Italy, Japan, Portugal, Singapore, Spain, United Kingdom
Product codes and lots: Systems Running Software Version 3.4 & 3.4.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1222-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1222-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-01	2019-04-25

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)