PlainRecordsFDA · Medical device recall
enGen Laboratory Automation System… and 1 more product
- Date
- Jan. 13, 2021
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- Ortho-Clinical Diagnostics, Inc.
- 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.
- Distribution pattern
- 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.
2 products in this recall
enGen Laboratory Automation System…
- 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).
- Quantity
- 40 units
- Codes and lots
- 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
- Recall started
- Nov. 20, 2020
- Device type
- Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Root cause (FDA)
- Software design
- What the company told customers
- 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.
- Recall number
- Z-0800-2021
VITROS Automation Solutions…
- Product
- VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.
- Quantity
- 40 units
- Codes and lots
- 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
- Recall started
- Nov. 20, 2020
- Device type
- Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Root cause (FDA)
- Software design
- What the company told customers
- 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.
- Recall number
- Z-0801-2021
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0800-2021, Z-0801-2021. The agency record governs; check it and the company before acting.