Z-1734-2014Class II

VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use

Name: Z-1734-2014 VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use
Creator: Ortho-Clinical Diagnostics
Published: 2014-04-10
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2014-04-10 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use on 2014-04-10. FDA classified it as Class II and gives the reason as "Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may...". 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-1734-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-10
Posted: 2014-06-09
Terminated: 2018-05-21
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected
Root cause tag: software
FDA root cause: Software design
Action: Important Product Correction Letters (CL2014-116, dated 4/10/2014) were sent on 4/10/2014 via FedEx overnight courier or ORTHO PLUS e-Communications to all customers with VITROS 5,1 FS, 5,1 FS Refurbished, 4600,and/or 5600 Systems. They were informed of the issue and advised to: -- Review VITROS ALT, ALTJ, ALKP, ALKPJ, AST, ASTJ, CHE, CHEJ, CK, CKJ, GGT, GGTJ, LDH and LDHJ results generated on VITROS 4600/5600 and 5,1 FS Systems. Do not report any results associated with an MW code. -- Perform repeat testing in singlicate on all samples with results having an MW code. Only results without an MW code are acceptable. -- Review their current Laboratory Information System (LIS) configuration to determine if changes are required in order to restrict reporting of results with an MW code. Customers with questions should contact Customer Technical Services at 1-800-421-3311. --- Foreign affiliates were informed of the issue by e-mail on 4/10/2014 and instructed to notify their consignees of the issue and actions.
Quantity in commerce: Domestic - 82, Foreign - 213 units
Distribution: Worldwide distribution including US Nationwide, Puerto Rico, 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 lower; Serial Numbers J46000108 through J46000403

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1734-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1734-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-09
Z-1735-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-09
Z-1736-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-09

Product code JJE

K031924Class IIVitros 5,1 Fs Chemistry System, Vitros Chemistry Products Dhdl Reagent Pack, Calibrator Kit 19, Fs Calibrator 1Ortho-Clinical Diagnostics / cleared 2003-08-07

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)