Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0968-2015·Announced 2015-01-21

Ortho VITROS 4600 Chemistry System Recalled for Software Calibration Error

Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because software versions 3.1 and below may fail to identify expired calibrations.

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 illnesses. The hazard is a software anomaly that may lead to improper identification of expired calibrations, which fits the criteria for a moderate severity recall involving potential risk without reported harm.

Plain-English summary

Ortho-Clinical Diagnostics is recalling the VITROS 4600 Chemistry System, a medical device used for in vitro quantitative measurement of clinical analytes. The recall involves 339 units distributed worldwide, including 102 in the United States and 237 in foreign countries.

The recall is due to a software anomaly identified in VITROS System Software Version 3.1 and below. The firm determined that the software may not properly identify an expired calibration. The affected units have serial numbers ranging from J46000108 to J46000492.

Healthcare facilities and users should check their VITROS 4600 Chemistry Systems for the affected software version and serial numbers. Users should contact Ortho-Clinical Diagnostics for instructions on how to resolve the issue.

The recalled product

Product: VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using…
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — Laboratory Equipment
Hazard: software-anomaly
calibration-error

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 (3)

Software Version 3.1 & Below
Serial Numbers J46000108 - J46000492 (the serial numbers are sequential
J Numbers are analogous to serial numbers)

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 3 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 3 products in this recall →

Same manufacturer · Ortho-Clinical Diagnostics

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Same hazard · software anomaly