Z-0079-2019Class II

VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative...

Name: Z-0079-2019 VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative...
Creator: Ortho-Clinical Diagnostics
Published: 2018-08-15
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2018-08-15 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical... on 2018-08-15. FDA classified it as Class II and gives the reason as "Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result". 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-0079-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-15
Posted: 2018-10-05
Terminated: 2022-01-10
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802413
Product code: JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Reason for recall: Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.
Root cause tag: software
FDA root cause: Software design
Action: ORTHO PLUSSM is e-Communications, a service that provides subscribing customers with Ortho Clinical Diagnostics (Ortho) product notifications electronically on 15 August 2018, a customer letter (Ref. CL2018-174) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received VITROS 5600 Integrated Systems to inform them of the potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result. Ortho also provided specific actions for customers to take when they observe unexpected MicroSlide assay results for a sample associated with TE1-504 and/or TE1-594 condition codes. Customers were also instructed to discuss any concerns related to this issue and previously reported results with the Laboratory Medical Director.
Quantity in commerce: U.S.= 1255 ex-U.S.= 1504
Distribution: Nationwide Foreign: France, Brazil, Chile, Great Britain, Phillippines, Spain
Product codes and lots: Serial Numbers : J56000024 through J56003300

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0079-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0079-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-17	2018-10-05
Z-0080-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-17	2018-10-05

Product code JLW

K081543Class IIVitros Immunodiagnostic Products Tsh Reagent Pack and Calibrators, Vitros 5600 Integrated SystemOrtho-Clinical Diagnostics, Inc. / cleared 2008-10-23

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)