CLASS II Device recall · Reported 1 Aug 2012 · FDA Enforcement Report

Vitros 5600 Integrated System recalled by Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics is recalling Vitros 5600 Integrated System, distributed nationwide in the US. The recall was initiated on 21 May 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVersion 2.0 & Below

Quantity recalled1387

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-2068-2012
FDA event ID: 61910
Recalling firm: Ortho-Clinical Diagnostics, Rochester, NY
Classification: Class II
Status: Terminated
Recall initiated: 21 May 2012
FDA classified: 23 Jul 2012
Reported: 1 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Medical Software

Timeline

21 May 2012	Recall initiated by company
23 Jul 2012	Classified by FDA	+63 days
1 Aug 2012	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

software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment.

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 5600 Integrated System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.

Where it was distributed

Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Brazil, Canada, Chile, Argentina, Paraquay, Ecuador, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, UK, Northern Europe, France, Germany, Italy, Spain and Portugal.

Nationwide

Questions about this recall

Is Vitros 5600 Integrated System recalled?

Yes. Ortho-Clinical Diagnostics recalled Vitros 5600 Integrated System on 21 May 2012. The recall is Class II and its status is Terminated. Recall number Z-2068-2012.

Why was it recalled?

Which lots are affected?

Version 2.0 & Below

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 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.

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