Z-0077-2015Class II

VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS...

Name: Z-0077-2015 VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS...
Creator: Ortho-Clinical Diagnostics
Published: 2014-09-08
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2014-09-08 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is intended for use in the in... on 2014-09-08. FDA classified it as Class II and gives the reason as "Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when using calibrator...". 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-0077-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-08
Posted: 2014-10-16
Terminated: 2018-05-21
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targets are unassigned (i.e., hidden).
Root cause tag: software
FDA root cause: Software design
Action: On 9/08/14, URGENT PRODUCT CORRECTION NOTIFICATION Letter (CL2014-232, dated 9/8/14) and Confirmation of Receipt Form were sent via FedEx overnight courier or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (OCD Direct, Drop-Ship and US Federal Government only) to inform them of the issue and advise them of the required actions. Foreign affiliates were informed of the issue via e-mail on 9/8/14 and instructed to notify their consignees of the issue and the required actions.
Quantity in commerce: USA: 97; Foreign: 232
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
Product codes and lots: Software Version 3.0 and below; Serial Numbers J46000012 - J46000456 (serial numbers are sequential; J Numbers are analogous to serial numbers)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0077-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0077-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-22	2014-10-16
Z-0078-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-22	2014-10-16

Product code JJE

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)