Recall Z-0800-2021 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics, Inc.
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 an
| Date | Jan 7, 2021 (initiated Nov 20, 2020) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.