Z-2139-2014Class II

VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and...

Name: Z-2139-2014 VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and...
Creator: Ortho-Clinical Diagnostics
Published: 2014-07-07
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2014-07-07 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of... on 2014-07-07. FDA classified it as Class II and gives the reason as "Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with...". 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-2139-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-07
Posted: 2014-08-01
Terminated: 2018-05-21
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS 3600 Immunodiagnostic System --- 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. The VITROS Software is a part of the VITROS 3600, 4600, & 5600 Systems. The VITROS 3600, 4600, & 5600 Systems share the same software base. VITROS Sample Programming consists of Sample Identification (SID), test requests, and patient demographics. Patient demographics include patient name, address, date of birth, gender, physician, and patient identification (PID).
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: On 7/07/2014, Customer Letter (Ref. CL2014-191) was 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) to inform them of the issue and advise them of the required actions. On 7/07/2014, Distributor Letter (Ref. DL2014-191 was sent via US Postal Service Priority Mail and/or FedEx overnight courier to US Distributor consignees instructing them to notify their consignees of the issue and required actions. Foreign affiliates were informed by e-mail on 7/07/2014 of the issue and instructed them to notify their consignees of the issue and required actions. For questions, please contact Customer Technical Services at 1-800-421-3311.
Quantity in commerce: Domestic: 142, Foreign: 536
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: Serial Numbers J36000101 - J36000806 (J Numbers are analogous to Serial Numbers and for VITROS 3600 systems the J Numbers start with 3600XXXX)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2139-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2139-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-01
Z-2140-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-01
Z-2141-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-01

Product code JJE

K083173Class IIVitros Immunodiagnostic Products Tsh Reagent Pack and Calibrators, Vitros 3600 Immunodiagnostic SystemOrtho-Clinical Diagnostics / cleared 2008-12-22

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)