Ortho-Clinical VITROS 5,1 FS Chemistry System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry System software due to a defect that allows improper sample metering for urine assays requiring acidification.
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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Ortho-Clinical Diagnostics is recalling the VITROS 5,1 FS Chemistry System, Software Version 2.8 and below. The recall involves 2,387 units distributed worldwide, including 987 units in the United States and 1,400 units internationally. The affected product codes are 6801375 and 6801890, with Unique Device Identifier Numbers 10758750001132 and 10758750001644.
The recall is due to a software anomaly affecting urine samples that require acidified pretreatment. The software allowed urine samples for assays requiring acidified pretreatment to be metered from the same sample container as assays that required no pretreatment when the sample was programmed. This defect may affect the accuracy of in vitro diagnostic results for VITROS Calcium, Magnesium, and Phosphorus assays.
The recall is classified as Class II by the FDA. Users of the affected software should contact Ortho-Clinical Diagnostics for instructions on how to resolve the issue.
The recalled product
- Product
- VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment
- 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 (3)
- Product Code: 6801375
- 6801890 Unique Device Identifier Numbers: 10758750001132
- 10758750001644
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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