Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1073-2016·Announced 2016-03-16

Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems Due to Error Codes

Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because they may generate specific error codes when used with a recalled Calibrator Kit 9 lot.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or deaths. The hazard is limited to the generation of specific error codes, which aligns with the criteria for a moderate severity score involving low-risk issues or voluntary precautionary measures without reported harm.

Plain-English summary

Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems, Catalog Number 6802445, with Software Version 3.2 and below and Serial Numbers J46000001 through 46000678. The recall involves 163 units in the United States and 286 units in foreign markets.

The recall was initiated because the systems may generate increased U90-382 or 6LU condition codes when used with Calibrator Kit 9, Lot 954. The company noted a trend of complaints regarding customer actions following these specific condition codes. This issue is related to a previous recall of the Calibrator Kit 9, Lot 954.

The affected devices are distributed worldwide, including the United States (nationwide including Puerto Rico) and countries such as Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela. Users should contact Ortho-Clinical Diagnostics for further instructions on how to proceed with the recall.

The recalled product

Product: VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD. Product Usage: For in vitro diagnostic use. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of…
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — In Vitro Diagnostic (IVD)
Hazard: software-error
mis-labeling

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 (2)

Software Version 3.2 and below
Serial Numbers J46000001 - 46000678

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

Same manufacturer · Ortho-Clinical Diagnostics

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Same hazard · software error