Z-1004-2015Class III

VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS...

Name: Z-1004-2015 VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS...
Creator: Ortho-Clinical Diagnostics
Published: 2014-09-29
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2014-09-29 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1)... on 2014-09-29. FDA classified it as Class III and gives the reason as "Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2". 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-1004-2015
Classification: Class III
Status: Terminated
Initiated: 2014-09-29
Posted: 2015-01-20
Terminated: 2017-04-03
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 - in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 - in vitro quantitative, semi-quantitative, and qualitative measurement of analytes
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: Ortho Clinical Diagnostics sent an Important Product Correction Notification letter dated September 29, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2. The resolution to this software anomaly will be in a future version of software. Until the new software is installed on their VITROS System, customers were instructed not to use the calibrator barcode labels for VITROS Calibrator Kit 2. Customers were advised that you manually program the calibration. Customers with questions were instructed to contact Customer Technical Services at 1-800-421-3311.
Quantity in commerce: 12 units
Distribution: Worldwide Distribution - USA including CO, NC, NJ, NY, PA, MI, WV and Internationally to Canada, Japan and Spain.
Product codes and lots: System Product Code: 1) 6802445, 2) 6802413

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1004-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1004-2015	Class III	Terminated	Voluntary: Firm initiated	2015-01-28	2015-01-20

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)