Moderate FDA (Devices)·Z-0968-2014·Announced 2014-02-19

Ortho-Clinical Diagnostics Recalls VITROS Chemistry Mixing Cup Arrays

Ortho-Clinical Diagnostics is recalling VITROS Chemistry Mixing Cup Arrays used on VITROS 250 and 350 systems due to an increase in software errors.

What this means for you

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, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.

Plain-English summary

Ortho-Clinical Diagnostics has issued a product correction notification for VITROS Chemistry Mixing Cup Arrays. These disposable, intermediate containers are used to make automatic dilutions on VITROS 250 and VITROS 350 Chemistry Systems. The recall involves 6,380 units, with each unit containing 48 arrays with 10 microcups.

The reason for the recall is an increase in software errors associated with the affected Mixing Cup Arrays. The FDA has classified this as a Class II recall.

The affected products were distributed worldwide, including the United States, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Puerto Rico, the Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain. Users of these systems should stop using the affected Mixing Cup Arrays and contact Ortho-Clinical Diagnostics for further instructions.

The recalled product

Product: VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry Syste
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — In Vitro Diagnostics
Hazard: software-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 (6)

1) VITROS 250 (Product Code 8132086
Model # 3332)
2) VITROS 350 (Product Code 6802153
Model # 3330)
3) Mixing Cup Arrays (Product Code 1631779
Model # n/a)

Distribution

Distributed nationwide across the United States.

Same manufacturer · Ortho-Clinical Diagnostics

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