Z-0801-2021 Class II Terminated
FDA device recall Z-0801-2021 was initiated by Ortho-Clinical Diagnostics, Inc. on November 20, 2020 and is designated Class II. 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 i… The recall status is terminated (terminated October 24, 2023). Affected quantity: 40 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 13, 2021
- Initiation Date
- November 20, 2020
- Termination Date
- October 24, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 units
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.
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.
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