—#149527

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).

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K063144
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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:RA-OCDUS-CONFIRMAD@ORTHOCLINICALDIAGNOSTICS.COM. 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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2016-09-07
Terminated: 2018-06-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #149527. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.