Recall Z-0801-2021
Ortho-Clinical Diagnostics, Inc. · initiated November 20, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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
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: Software design
Action taken
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.
Details
- Recall number
- Z-0801-2021
- Initiated
- November 20, 2020
- Posted by FDA
- January 7, 2021
- Terminated
- October 24, 2023
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- 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.
- Recalling firm
- Ortho-Clinical Diagnostics, Inc., Rochester, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0800-2021 Class II | enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product…A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to… | 11/20/2020Terminated |