Z-2879-2020Class II

VITROS XT7600 Integrated System, Product code 6844461

Name: Z-2879-2020 VITROS XT7600 Integrated System, Product code 6844461
Creator: Ortho Clinical Diagnostics
Published: 2020-07-20
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2020-07-20 / Terminated / root cause: manufacturing process

FDA source

Ortho Clinical Diagnostics began a recall of VITROS XT7600 Integrated System, Product code 6844461 on 2020-07-20. FDA classified it as Class II and gives the reason as "When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2879-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-20
Posted: 2020-08-24
Terminated: 2023-12-18
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS XT7600 Integrated System, Product code 6844461
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm notified customers through Urgent Product Correction Notification letters on July 20, 2020. Customers were informed of the potential issue with incubator slot 18 of affected devices. Customers were provided with a table of the eight assays with biases which do not align with the assay's intended clinical use. Customers who had already been identified as experiencing this issue through their e-connected systems, or who did not have e-connected systems, received a letter stating that the recalling firm would be replacing the CM Rotor to resolve the issue. Customers who had e-connected systems but who had not yet been identified as experiencing this issue were informed that Ortho would continue to monitor their system for an increase in the frequency of condition codes related to slide misalignment. If impacted, those customers would also receive a replacement CM Rotor. Customer actions: " If you suspect an erroneous result has occurred or you observe an increase in the frequency of TH4-60J/TH4-63J condition codes, contact Ortho Care Technical Solutions Center. " Review the enclosed Assay Observed Bias sheet for VITROS Slides assays used by your laboratory. Discuss any concerns with your Laboratory Medical Director. " Complete the Confirmation of Receipt form and return to the firm " Post this notification by each VITROS XT 3400 and/or XT 7600 System in your facility or with the user documentation.
Quantity in commerce: pending
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
Product codes and lots: Serial numbers J76000050 - 76000566

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2879-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2878-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-24
Z-2879-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-24

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)