Z-1742-2015Class II

VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical...

Name: Z-1742-2015 VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical...
Creator: Ortho-Clinical Diagnostics
Published: 2015-04-06
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2015-04-06 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use on 2015-04-06. FDA classified it as Class II and gives the reason as "Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results". 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-1742-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-06
Posted: 2015-06-09
Terminated: 2018-05-25
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results.
Root cause tag: software
FDA root cause: Software design
Action: On April 6, 2015, Ortho Clinical Diagnostics distributed correction notification letters and response forms to their customers via courier service. All urine patient results that require pretreatment was advised to refer to the notice of correction for instructions. Correction notices should also be posted beside the device user documentation for easy reference. Customers were advised to complete and return the Confirmation of Receipt before April 20, 2015. Customers with questions may contact the Customer Technical Service at 1-800-421-3311 anytime..***CAPA***Since the Assay Data Disk (ADD) provides data tables that determine which assays can be tested from the same sample container, an updated ADD is being created to address the anomaly on the VITROS 4600 and 5600. The anomaly will be addressed with an updated ADD is uploaded and the revised ADD mitigates the issue totally. Anticipated date of availability TBD.
Quantity in commerce: 255 units total (131 domestically & 255 internationally)
Distribution: Worldwide Distribution-US (nationwide), Brazil, Chile, Mexico, Australia, Hong Kong, India, Taiwan, Belgium, Denmark, France, Ireland, Italy, Portugal, Romania, Spain, Sweden and the UK.
Product codes and lots: Product Code: 6802445 Unique Device Identifier No.: 10758750012343

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1742-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1742-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-09
Z-1743-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-09

Product code JJE

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