VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.
Reported: January 13, 2021 Initiated: November 20, 2020 #Z-0801-2021
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.
Details
- Recalling Firm
- Ortho-Clinical Diagnostics, Inc.
- Units Affected
- 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.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.. Recalled by Ortho-Clinical Diagnostics, Inc.. Units affected: 40 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 13, 2021. Severity: Moderate. Recall number: Z-0801-2021.
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