Z-0300-2017Class II

enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module...

Name: Z-0300-2017 enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module...
Creator: Ortho-Clinical Diagnostics
Published: 2016-09-07
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2016-09-07 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and Below... on 2016-09-07. FDA classified it as Class II and gives the reason as "Ortho confirmed that it is possible for the mis-association of sample identification and assay results due to an error with Thermo Fishers centrifuge module. It is possible for mis-associated assay results to be...". 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-0300-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-07
Posted: 2016-10-22
Terminated: 2018-06-15
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and Below; IVD. --- Thermo Scientific Centrifuge Module has Product Code 952040-EG 6844097. The VITROS 5,1 FS Chemistry System with enGen Laboratory Automation 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 confirmed that it is possible for the mis-association of sample identification and assay results due to an error with Thermo Fishers centrifuge module. It is possible for mis-associated assay results to be reported from the laboratory prior to the identification of the Cross Check error on the enGen Laboratory Automation System. Assay results associated with the wrong patient and reported out of the laboratory could lead to inappropriate intervention with the potential for serious injury to the patient.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Ortho Clinical Diagnostics, sent an "URGENT PRODUCT CORRECTION NOTIFICATION" Letter (Ref. CL2016-183, dated 9/7/2016) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all enGen customers with centrifuge modules to inform them of the issue and advise them to check samples associated with cross check errors as instructed in the operator manual, and perform the preventative maintenance and cleaning procedures for that centrifuge module as provided in the maintenance manual and user guide. The customers were also instructed to Complete and return the Confirmation of Receipt form by 16 September 2016 via Fax: 1.888.557.3759 or 1.585.453.4110 or email:[email protected]. For questions regarding this notification, please call the Ortho Care Solutions Center any time at 1-800-421-3311. Foreign affiliates were informed by e-mail on 9/7/2016 of the issue and instructed to notify their consignees of the issue and appropriate actions to take.
Quantity in commerce: 60 (US: 24; Foreign: 36)
Distribution: Worldwide Distribution-(Nationwide) and foreign distribution to the following countries: Belgium, Bermuda, Canada, Chile, Denmark, France, Italy, Mexico, Norway, Portugal, Sweden, Taiwan and United Kingdom.
Product codes and lots: Software Versions 3.6.1 and below; Affected US Serial Numbers: 5GV6W2J,GBX395J, J2QKG25J, 2Z3YV1J, 3RHC23J, 4HX7S4J, 54FC01J, 5J4B45J, 736BM4J, 7KSC15J, J86PWC5J, 953209, 953221, 953266, 953270, B3ZHP2J, CXL941J, JFBX395J, FCM073J, FXCBG3J, JG7BFB5J, GWXQ52J, HJ5K84J, HPKG25J -- Affected Foreign Serial Numbers: DWXO52J, GWJZY4J, J16XQH4J, BGV6W2J, 17QP94J, 4SHPF4J, 1K5K84J, 37QP34J, H5PWC5J, J2V6LW4J, F6MXR3J, JT6LW4J, N0551107, F1150698, 46XQH4J, 2S5OP0J, CRKM82, J41BCY4J, J56T205J, BGV6W2J, 7YCF43J, 96XQHAJ, C1JNZ5J, C3JTP4J, D3JTP4J, 86T205J, 18BFB5J, 96PWC5J, 1LSSF5J, 4drj44j, 8W7WG3J, J953222, J953244, JCT20Q3J, HWJZY4J, 38769917923.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0300-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0300-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-22

Product code JJE

K063144Class IVitros 5,1 Fs Chemistry System with Engen Laboratory Automation SystemOrtho-Clinical Diagnostics, Inc. / cleared 2006-11-13

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)