CLASS III Device recall · Reported 28 Jan 2015 · FDA Enforcement Report

Vitros Software Version 3.1 utilized on the following systems: 1) recalled

Ortho-Clinical Diagnostics is recalling Vitros Software Version 3.1 utilized on the following systems: 1), distributed nationwide in the US. The recall was initiated on 29 Sep 2014 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesSystem Product Code: 1) 6802445, 2) 6802413

Quantity recalled12 units

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-1004-2015
FDA event ID: 69727
Recalling firm: Ortho-Clinical Diagnostics, Rochester, NY
Classification: Class III
Status: Terminated
Recall initiated: 29 Sep 2014
FDA classified: 20 Jan 2015
Reported: 28 Jan 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

29 Sep 2014	Recall initiated by company
20 Jan 2015	Classified by FDA	+113 days
28 Jan 2015	Published in enforcement report	+8 days

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

Reason for recall

Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.

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 Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 - in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 - in vitro quantitative, semi-quantitative, and qualitative measurement of analytes

Where it was distributed

Worldwide Distribution - USA including CO, NC, NJ, NY, PA, MI, WV and Internationally to Canada, Japan and Spain.

Nationwide Colorado Michigan North Carolina New Jersey New York Pennsylvania West Virginia

Questions about this recall

Is Vitros Software Version 3.1 utilized on the following systems: 1) recalled?

Yes. Ortho-Clinical Diagnostics recalled Vitros Software Version 3.1 utilized on the following systems: 1) on 29 Sep 2014. The recall is Class III and its status is Terminated. Recall number Z-1004-2015.

Why was it recalled?

Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.

Which lots are affected?

System Product Code: 1) 6802445, 2) 6802413

Where was it sold?

Worldwide Distribution - USA including CO, NC, NJ, NY, PA, MI, WV and Internationally to Canada, Japan and Spain.

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Ortho-Clinical Diagnostics

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24 Sep 2025Device	CLASS II	Chemistry Products LAC Slides recalled by Ortho-Clinical Diagnostics	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
24 Sep 2025Device	CLASS II	Vitros Chemistry Products LAC Slides recalled	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
27 Aug 2025Device	CLASS II	Vitros Chemistry Products Ca Slides recalled	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
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