CLASS II Device recall · Reported 26 Dec 2018 · FDA Enforcement Report

Vitros¿ 3600 Immunodiagnostic System recalled

Ortho-Clinical Diagnostics is recalling Vitros¿ 3600 Immunodiagnostic System, distributed nationwide in the US. The recall was initiated on 19 Oct 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: 6802783 UDI 10758750002979 Product Code: 6802914 UDI 10758750007103 Serial Numbers: J36000109-J36001169

Quantity recalled682

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-0652-2019
FDA event ID: 81563
Recalling firm: Ortho-Clinical Diagnostics, Rochester, NY
Classification: Class II
Status: Terminated
Recall initiated: 19 Oct 2018
FDA classified: 20 Dec 2018
Reported: 26 Dec 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Spinal Implants

Timeline

19 Oct 2018	Recall initiated by company
20 Dec 2018	Classified by FDA	+62 days
26 Dec 2018	Published in enforcement report	+6 days

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

Reason for recall

Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.

Which lots are affected?

Product Code: 6802783 UDI 10758750002979 Product Code: 6802914 UDI 10758750007103 Serial Numbers: J36000109-J36001169

Where was it sold?

US Nationwide Distribution

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.

Other products in this recall event

3 other products · FDA event 81563

This product is part of a recall event; the main page for the event is Vitros 5,1 FS Chemistry System recalled by Ortho-Clinical Diagnostics.

Reported	Class	Recall	Company	Reason	Where
26 Dec 2018	CLASS II	Vitros 5,1 FS Chemistry System recalled by Ortho-Clinical Diagnostics	Ortho-Clinical Diagnostics	Potency & Assay	Nationwide
26 Dec 2018	CLASS II	Vitros 4600 Chemistry System recalled by Ortho-Clinical Diagnostics	Ortho-Clinical Diagnostics	Potency & Assay	Nationwide
26 Dec 2018	CLASS II	Vitros 5600 Integrated System recalled by Ortho-Clinical Diagnostics	Ortho-Clinical Diagnostics	Potency & Assay	Nationwide

More recalls from Ortho-Clinical Diagnostics

All 311

Reported	Class	Recall	Company	Reason	Where
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
23 Jul 2025Device	CLASS II	Vitros Chemistry Products CHE Slides (Japan) recalled	Ortho-Clinical Diagnostics	Labeling Errors	Nationwide
23 Jul 2025Device	CLASS II	Vitros Chemistry Products CHE Slides recalled	Ortho-Clinical Diagnostics	Labeling Errors	Nationwide

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All 1,159

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