CLASS II Device recall · Reported 26 Dec 2018 · 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 19 Oct 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) Product Code 6802413 UDI 10758750002740; Serial Numbers J56000024 J56003358 2) Product Code 6802915 (Refurbished) UDI 10758750007110 Serial Numbers: 56000427 56000750 56001012 56001535 56001152 56001641 56000327 56000585 56001437 56000786 56000255 56001235 56000792 56001062 56000308 56001184 56000315 56000458 56001570 56000825 56000661 56000261 56000559 56000818 56000747 56001139 56000317 56000513 56000755 56000883 56001334 56001445 56001141 56000756 56000824 56000718 56001021 56000339 56000741 56000727 56001131 56001558 56001530 56001089 56001264 56000646 56000655 56001027 56001128 56000796 56000890 56000928 56001359 56001851 56000533 56001111 56001689

Quantity recalled2413

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-0650-2019
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: Test Kits & Diagnostics

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 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.

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?

1) Product Code 6802413 UDI 10758750002740; Serial Numbers J56000024 J56003358 2) Product Code 6802915 (Refurbished) UDI 10758750007110 Serial Numbers: 56000427 56000750 56001012 56001535 56001152 56001641 56000327 56000585 56001437 56000786 56000255 56001235 56000792 56001062 56000308 56001184 56000315 56000458 56001570 56000825 56000661 56000261 56000559 56000818 56000747 56001139 56000317 56000513 56000755 56000883 56001334 56001445 56001141 56000756 56000824 56000718 56001021 56000339 56000741 56000727 56001131 56001558 56001530 56001089 56001264 56000646 56000655 56001027 56001128 56000796 56000890 56000928 56001359 56001851 56000533 56001111 56001689

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¿ 3600 Immunodiagnostic System recalled	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

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

Other Test Kits & Diagnostics recalls

All 2,661

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	McKesson Consult hCG Urine Cassette recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
7 Oct 2026Device	CLASS II	Systems/units containing affected recalled	Beckman Coulter Mishima K.K	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
30 Sep 2026Device	CLASS II	Vitek 2 Ast-N461 Test Kit, Gram Negative Susceptibility recalled	Biomerieux	Other	MO
23 Sep 2026Device	CLASS II	DASH Rapid PCR Instrument recalled by Nuclein	Nuclein	Device Malfunction	Nationwide