Ortho-Clinical VITROS 5,1 FS Chemistry System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems because a software anomaly may cause the device to process assays at incorrect temperatures, potentially producing erroneous 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 (erroneous clinical results) 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 and VITROS 5,1 FS Chemistry System Refurbished, specifically units running Software Version 2.8 and below. The recall affects specific serial numbers for both the standard and refurbished models.
The recall is due to a software anomaly that may allow the systems to sample and process assays while fluids and reagent temperatures are not within the required range for optimal processing. When this intermittent issue occurs, the systems continue to operate and process results without notifying the user, which may result in erroneous test outcomes.
The affected products were distributed worldwide, including the United States, Puerto Rico, and numerous foreign countries. The source text does not specify a corrective action for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this recall.
The recalled product
- Product
- VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Unique Device Identifier Number 10758750001644, Software Version 2.8 and below, IVD. Product Usage:
- 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 (20)
- Software Version 2.8 and below
- VITROS 5
- 1 FS Chemistry System Serial Numbers J34000016 - J34002323
- 1 FS Chemistry System Refurbished Serial Numbers 34000133
- 34000193
- 34000197
- 34000212
- 34000285
- 34000316
- 34000318
- 34000337
- 34000360
- 34000420
- 34000451
- 34000478
- 34000495
- 34000497
- 34000529
- 34000538
- 34000552
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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