Ortho-Clinical VITROS 5,1 FS Chemistry System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems with software version 2.8 or below due to a potential anomaly that may cause the device to process samples with the wrong cartridge, leading to erroneous patient results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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. The hazard involves a risk of harm (erroneous patient results) where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems and VITROS 5,1 FS Chemistry System Refurbished units equipped with software version 2.8 or below. The recall involves specific catalog numbers and serial numbers distributed worldwide, including in the United States, Puerto Rico, and various international locations.
The recall is due to a software anomaly that may allow the device to process samples with a cartridge other than the intended one. This error could potentially lead to erroneous patient results. If this anomaly has occurred, it may be indicated by a series of similar results across multiple samples, which could appear believable or fall outside the reportable range for the intended assay.
Healthcare facilities and users of these devices should contact Ortho-Clinical Diagnostics for instructions on how to resolve the software issue. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Global Trade Item Number 10758750001644; IVD. Intended for use in the in…
- 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 & Below
- VITROS 5
- 1 FS Chemistry System Serial Numbers 34000119 - 34002323
- 1 Refurbished: Serial Numbers - Domestic S/Ns: 34000133
- 34000193
- 34000197
- 34000212
- 34000285
- 34000316
- 34000318
- 34000337
- 34000360
- 34000420
- 34000451
- 34000464
- 34000478
- 34000495
- 34000497
- 34000529
- 34000538
Distribution
Distributed in 1 state:
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