Z-1293-2019Class II

VITROS ECi Immunodiagnostic System Refurbished

Name: Z-1293-2019 VITROS ECi Immunodiagnostic System Refurbished
Creator: Ortho-Clinical Diagnostics
Published: 2019-02-20
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2019-02-20 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a... on 2019-02-20. FDA classified it as Class II and gives the reason as "Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems". 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-1293-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-20
Posted: 2019-05-06
Terminated: 2021-09-15
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Product code: KHO Fluorometer, For Clinical Use
Reason for recall: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
Root cause tag: software
FDA root cause: Software design
Action: Ortho Clinical Diagnostics (Ortho) issued an "URGENT PRODUCT CORRECTION NOTIFICATION" , a customer letter (Ref. CL2019-052) dated 21 February 2019 via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to customers who were shipped affected VITROS Systems/or whose VITROS System has a luminometer parts replacement. The customers were notified of the issue and instructed to notify Ortho upon experiencing the issue described: -Avoid performing a shutdown/restart on your systems unless directed by an Ortho representative or prompted by condition code help text. -If you shutdown/restart and encounter any of the above Luminometer condition codes and are unable to process MicroWell assays, immediately contact the Ortho Care" Technical Solutions Center for service to your system. -Complete the enclosed Confirmation of Receipt form no later than March 1, 2019 by Fax: 1.888.557.3759 or 1.585.453.4110 or e-Mail Address: [email protected]. -Please forward this notification if the product was distributed outside of your facility. Foreign affiliates were informed by email on 21 February 2019 of the issue and instructed to notify affected consignees of the issue and appropriate actions to take. Questions contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
Quantity in commerce: 25 units
Distribution: Worldwide Distribution: US (Nationwide) and 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, and United Kingdom.
Product codes and lots: Serial Numbers: Systems that had the Luminometer component replaced during a service-repair. UDI: 10758750001040

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1293-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1287-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-06
Z-1288-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-06
Z-1289-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-06
Z-1290-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-06
Z-1291-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-06
Z-1292-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-06
Z-1293-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-06

Product code KHO

K962919Class IVitros Immunodiagnostic SystemJohnson & Johnson Clinical Diagnostics, Inc. / cleared 1996-10-18

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)