| Class 2 Device Recall enGen Laboratory Automation System |  |
Date Initiated by Firm | November 20, 2020 |
Date Posted | January 07, 2021 |
Recall Status1 |
Terminated 3 on October 24, 2023 |
Recall Number | Z-0800-2021 |
Recall Event ID |
86972 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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Product | enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: 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). |
Code Information |
enGen Laboratory Automation Systems and VITROS Automation Solutions Using All TCAutomationTM configured with Thermo Scientific Aliquoter & Labeller Module and using Software Versions 4.6 and below |
Recalling Firm/ Manufacturer |
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr Rochester NY 14626-5101
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For Additional Information Contact | Mr. Joe Falvo 585-453-3000 |
Manufacturer Reason for Recall | A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample and potentially lead to inappropriate intervention with the potential for injury to the patient. |
FDA Determined Cause 2 | Software design |
Action | On November 20, 2020, the firm sent Urgent Product Correction Notification letters to affected customers to inform them of the issue. Customers were reminded to follow product labelling regarding removing all tubes before performing maintenance or initializing the Aliquoter & Labeller Module. There should never be sample tubes present when initializing the Aliquoter & Labeller module.
The firm's release of TCA Software version 4.7 is the planned mitigation for this issue.
If you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311. |
Quantity in Commerce | 40 units |
Distribution | Worldwide distribution - US Nationwide distribution including the states of CA, CO, MA, MD, NC, OH, TX, VA, VT, and Belgium, Bermuda, Canada, China, France, Italy, Japan, Mexico, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom. |
Total Product Life Cycle | TPLC Device Report |
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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.
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