Agency classClass IIOur severity:High FDA (Devices)·Z-1742-2015·Announced 2015-06-17

Ortho-Clinical VITROS 4600 Chemistry System Software Recall

Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry System software versions 3.2 and below due to a defect that may allow multiple assays to be tested on a single urine specimen, potentially leading to biased 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 potential biased patient results due to a software defect, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Ortho-Clinical Diagnostics is recalling the VITROS 4600 Chemistry System, specifically 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 255 units total, with 131 distributed domestically in the United States and 255 distributed internationally.

The recall is being issued 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 defect potentially leads to biased patient results. The affected units were distributed worldwide, including in the US, Brazil, Chile, Mexico, Australia, Hong Kong, India, Taiwan, Belgium, Denmark, France, Ireland, Italy, Portugal, Romania, Spain, Sweden, and the UK.

Healthcare facilities and users of the VITROS 4600 Chemistry System should contact Ortho-Clinical Diagnostics for instructions on how to address the software anomaly. The product code is 6802445 and the Unique Device Identifier is 10758750012343.

The recalled product

Product: VITROS 4600 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
Category: Medical Device — In Vitro Diagnostic
Hazard: software-defect
biased-results

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: 6802445 Unique Device Identifier No.: 10758750012343

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.

See all 2 products in this recall →

Same manufacturer · Ortho-Clinical Diagnostics

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