Recall Z-0801-2021— Ortho-Clinical Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Ortho-Clinical Diagnostics, Inc., initiated 2020-11-20, terminated 2023-10-24. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-20
- Terminated
- 2023-10-24
- Firm location
- Rochester, NY, United States
Product description
VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.