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U.S. Department of Health and Human Services

Class 2 Device Recall enGen (TM) Laboratory Automation Systems

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  Class 2 Device Recall enGen (TM) Laboratory Automation Systems see related information
Date Initiated by Firm March 08, 2017
Create Date May 12, 2017
Recall Status1 Terminated 3 on August 24, 2021
Recall Number Z-2077-2017
Recall Event ID 76752
510(K)Number K063144  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD
Code Information US Serial Numbers/J Numbers: B3ZHP2J/JB3ZHP2J; 736BM4J/J736BM4J; 953289/J953289; 953252/J953252; HJ5K84J/JHJ5K84J; FCM073J/JFCM073J; HPKG25J/JHPKG25J; GWXQ52J/JGWXQ52J; GBX395J/GBX395J; JFBX395J/JFBX395J; FXCBG3J/JFXCBG3J; 3RHC23J/J3RHC23J; JG7BFB5J/JG7BFB5J; 953270/J953270; 953221/J953221; 54FC01J/J54FC01J; 953209/J953209; 5J4B45J/J5J4B45J; 5LQ6Q2J/ J5LQ6Q2J; 2Z3YV1J/J2Z3YV1J; FRKMB2J/JFRKMB2J; 5GV6W2J/5GV6W2J; 7KSC15J/J7KSC15J; 953276/J953276; J2QKG25J/J2QKG25J; DK2BG3J/JDK2BG3J; 953266/J953266; J86PWC5J/ J86PWC5J; JXBQW4J/JJXBQW4J; CXL941J/JCXL941J; J953224/J953224; 36PWC5J/J36PWC5J; 4HX7S4J/J4HX7S4J --- Foreign Serial Numbers/J #s: CRKM82/J31265; 2S5OP0J/J31067; C4Z655J/ J31421; 6VR7K4J/J31401;  90JYS22/J31350; HWJZY4J/JHWJZY4J; J3J4B45J/J3J4B45J; JCT20Q3J/JCT20Q3J; J953234/J953234; J41BCY4J/J41BCY4J; J953244/J953244; J1HX7S4J/ J1HX7S4J; J16XQH4J/J16XQH4J; GWJZY4J/ GWJZY4J; DWXO52J/DWXO52J; 17QP94J/J20022; BGV6W2J/ J20003; H5PWC5J/J271371; 2LSSF5J/J271377; 1K5K84J/ J271264; 8W7WG3J/J85206; 96XQHAJ/ J7023645; 1LSSF5J/J7025050; 86T205J/ J7024893; C3JTP4J/J7023847; D3JTP4J/J7023874; C1JNZ5J/J7023730;  7DRJ44J/J7023728; 7YCF43J/J7023435; 18BFB5J/J7025017; J953222/J953222; J2V6LW4J/J2V6LW4J; J56T205J/J56T205J; BGV6W2J/J57663; 4drj44j/J800103; 6KSC15J/J1801116; FWGFC4J/J75663;  7GV6W2J/J75615; BT9PB5J/ J75666; JT6LW4J/ J30372; 38769917923/JTAINAN1; F2250767/J3055503; F1150698/ J3055496.
Recalling Firm/
Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Ms. Jennifer Paine
Manufacturer Reason
for Recall
Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics, subsequently, confirmed a software anomaly that may potentially result in miss-associated sample IDs involving the communication between enGen TCAutomation (TCA) Bypass modules (manufactured by Thermo-Fisher Scientific) and the VITROS Analyzers. To date, no occurrences of this issue have been observed on Orthos enGen(TM) Systems. Sample IDs may become miss-associated with the actual sample being processed due to discrepant information passed to the analyzer through InOut communication device, triggered by a specific set of events occurring between the Bypass module and the analyzer. --- All of the following conditions must be present for the issue to potentially occur: (1.) The Bypass module is in the process of positioning Sample A at the aspiration position, and (2.) At least two additional sample tubes (Samples B and C) are waiting to be aspirated in the Bypass module queue, and (3.) A Radio Frequency Identification (RFID) Tag Read failure occurs on the Sample A carrier, and (4.) The VITROS System is not available to aspirate on the track (for example, the analyzer is initializing, or the user is making entries on the diagnostic screen, or samples are being aspirated from the front of the analyzer, etc.). --- If the software anomaly occurs and the issue is present, the Sample ID in the INOUT communication device software queue becomes asynchronous with the actual Sample ID physical queue, and the VITROS assay result will be reported for the wrong Sample ID. All subsequent samples will have miss-associated results until the Bypass module is reset or the queue is empty. --- This issue could potentially miss-associate a sample/patient ID with a test result of a different sample. Depending on the test involved, patients health condition, etc., the potential health risk posed to the affected patient could range from no risk to serious risk, and potentially could lead to misdiagnosis or inappropriate medical intervention. To date, no patient harm was reported related to this product issue.
FDA Determined
Cause 2
Software design
Action On 3/8/2017, URGENT PRODUCT CORRECTION NOTIFICATION letter (Ref. CL2017-059, dated 3/8/2017) 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 to inform them of the issue and provide them instructions on how to monitor and detect if the issue has potentially occurred. For questions or additional information, please contact Ortho Care Technical Solutions Center at 1-800-421-3311. Foreign affiliates were informed by e-mail on 3/8/2017 of the issue and instructed to notify their consignees of the issue and appropriate actions to take.
Quantity in Commerce US: 33 units; OUS: 43 units
Distribution MA, NJ, NY, NY, PA,DE, MD, WV, NC, GA, FL, TN, MS, OH, MI, IL, MO, NE, AR, TX, CO, ID, TX, CA and Foreign distribution to the following countries: Belgium, Bermuda, Brazil, Canada, Chile, Denmark, England, France, Italy, Mexico, Norway, Portugal, Romania, Singapore, Spain, Sweden, Taiwan, United Kingdom.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = Ortho-Clinical Diagnostics, Inc.