CLASS II Device recall · Reported 14 Aug 2019 · FDA Enforcement Report

Vitros 5600 Integrated System, clinical chemistry analyzer recalled

Ortho Clinical Diagnostics is recalling Vitros 5600 Integrated System, clinical chemistry analyzer, distributed nationwide in the US. The recall was initiated on 8 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesproduct code: 6802915 UDI: 10758750007110 Affected software : Version 3.3.2 or above

Quantity recalled89

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-2180-2019
FDA event ID: 83322
Recalling firm: Ortho Clinical Diagnostics, Rochester, NY
Classification: Class II
Status: Terminated
Recall initiated: 8 Jul 2019
FDA classified: 6 Aug 2019
Reported: 14 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

8 Jul 2019	Recall initiated by company
6 Aug 2019	Classified by FDA	+29 days
14 Aug 2019	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

Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

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, clinical chemistry analyzer

Where it was distributed

Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.

Nationwide Puerto Rico

Questions about this recall

Is Vitros 5600 Integrated System, clinical chemistry analyzer recalled?

Yes. Ortho Clinical Diagnostics recalled Vitros 5600 Integrated System, clinical chemistry analyzer on 8 Jul 2019. The recall is Class II and its status is Terminated. Recall number Z-2180-2019.

Why was it recalled?

Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

Which lots are affected?

product code: 6802915 UDI: 10758750007110 Affected software : Version 3.3.2 or above

Where was it sold?

Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.

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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