Ortho-Clinical VITROS 5600 Chemistry System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 5600 Chemistry Systems due to a software anomaly that may allow multiple assays to be tested on a single urine specimen, potentially leading to biased patient results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (biased patient results) where specific injury or illness has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Ortho-Clinical Diagnostics is recalling the VITROS 5600 Chemistry System, Software Version 3.2 and below. This device automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. The recall involves 1,895 units total, with 907 units distributed domestically in the United States and 988 units distributed internationally.
The recall is being conducted because a software anomaly allows the testing of multiple assays using a single urine specimen, regardless of the specific pretreatment requirements for each selected assay. This issue may potentially lead to biased patient results.
The affected units were distributed worldwide, including in the United States (nationwide), Brazil, Chile, Mexico, Australia, Hong Kong, India, Taiwan, Belgium, Denmark, France, Ireland, Italy, Portugal, Romania, Spain, Sweden, and the United Kingdom. Users of the VITROS 5600 Chemistry System should contact Ortho-Clinical Diagnostics for further instructions on how to address the software anomaly.
The recalled product
- Product
- VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
- Manufacturer
- Ortho-Clinical Diagnostics
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product Code: 6802413 Unique Device Identifier No.: 10758750002740
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ortho-Clinical Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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