CLASS II Device recall · Reported 19 Feb 2014 · FDA Enforcement Report

Vitros Chemistry Products Mixing Cup Arrays utilized recalled

Ortho-Clinical Diagnostics is recalling Vitros Chemistry Products Mixing Cup Arrays utilized on Vitros 250 & 350 Chemistry Systems, distributed nationwide in the US. The recall was initiated on 10 Oct 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) 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)

Quantity recalled6380 units (each unit contains 48 arrays with 10 microcups)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0968-2014
FDA event ID: 66498
Recalling firm: Ortho-Clinical Diagnostics, Rochester, NY
Classification: Class II
Status: Terminated
Recall initiated: 10 Oct 2013
FDA classified: 10 Feb 2014
Reported: 19 Feb 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

10 Oct 2013	Recall initiated by company
10 Feb 2014	Classified by FDA	+123 days
19 Feb 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Ortho Clinical Diagnostics issued a product correction notification for VITROS Chemistry Mixing Cup Arrays utilized on VITROS 250 and VITROS 350 Chemistry Systems. Increase in Software error due to affected Mixing Cup Arrays.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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 System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Microslides. The VITROS 350 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides.

Where it was distributed

Worldwide Distribution - US Nationwide and the countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, PR, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

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)

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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