Z-1222-2024Class II

VITROS XT7600 Integrated System

Name: Z-1222-2024 VITROS XT7600 Integrated System
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2024-01-22
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2024-01-22 / Open, Classified

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS XT7600 Integrated System on 2024-01-22. FDA classified it as Class II and gives the reason as "Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems which may lead to erroneous test results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1222-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-22
Posted: 2024-03-01
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS XT7600 Integrated System
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
FDA root cause: Component change control
Action: An URGENT PRODUCT CORRECTION NOTIFICATION letter dated 01/22/24 was sent to customers. REQUIRED ACTIONS: To reduce the risk of unintended sample aspiration, refer to the procedure provided in this notification titled, Temporary TRAY Loading Instructions . QuidelOrtho recognizes that the Temporary TRAY Loading Instructions procedure may not be tenable for all laboratories due to testing volumes. Review your laboratory risk management plan(s) to assess the need for this further mitigation. Acknowledge your understanding of this notification by completing the enclosed Confirmation of Receipt form no later than January 30, 2024. Save this notification with your User Documentation or post this notification by each VITROS 3600/5600/XT 7600 System until this issue has been resolved. If your laboratory has experienced the anomaly described in this notification and you have not already done so, please report the occurrence to your local Global Services Organization (formerly Ortho Care). QuidelOrtho has identified root cause however, our investigation is still ongoing. We are currently working on a Hardware Modification (MOD) to resolve this issue and will communicate again once the MOD or additional information is available. Current estimated availability date of the MOD is 2nd quarter 2024. If you have further questions, please contact our Global Services Organization at 1-800-421-3311.
Quantity in commerce: 1,720 units (834 US, 886 OUS)
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.
Product codes and lots: Code Information: UDI/DI: 10758750031610; Serial Numbers: J76000109 through J76001913 (inclusive).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1222-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1220-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1221-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1222-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01

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)