Agency classClass IIOur severity:High FDA (Devices)·Z-0643-2016·Announced 2016-01-20

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.

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, 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
Category: Medical Device — In Vitro Diagnostics
Hazard: erroneous-results
software-anomaly

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.

See all 4 products in this recall →

Same manufacturer · Ortho-Clinical Diagnostics

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Same hazard · erroneous results