Device recall: VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product…

Class II FDA enforcement event 72597. Recall start date: 3 Nov 2015. Status in the FDA record: Terminated. Termination date: 30 May 2018.

Reason for recall, in the words of FDA

Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Ortho-Clinical Diagnostics started this device recall on 3 Nov 2015. The firm address in the FDA record is in Rochester, NY. FDA put the recall in Class II. FDA event 72597 has 4 product records. The first FDA enforcement report date is 20 Jan 2016. The record gives the status Terminated, with the termination date 30 May 2018.

FDA enforcement report The 4 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution - US Nationwide and the countries of Puerto Rico, and foreign distribution to: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India,…

Recalling firm

Ortho-Clinical Diagnostics, Rochester, NY.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

4 product records in the event.

FDA event 72597: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0640-2016	VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest,…	Domestic: 200, Foreign: 554	Class II	Terminated	20 Jan 2016
Z-0641-2016	VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest,…	Domestic: 1083, Foreign: 999	Class II	Terminated	20 Jan 2016
Z-0642-2016	VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD. Product Usage: The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS…	Domestic: 157, Foreign: 270	Class II	Terminated	20 Jan 2016
Z-0643-2016	VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Unique Device Identifier Number 10758750001644, Software Version 2.8 and below, IVD. Product Usage: The VITROS 5,1 FS Chemistry System is…	VITROS 5,1: Domestic - 932, Foreign - 1245; 5,1 Refurbished: Domestic - 63; Foreign - 153	Class II	Terminated	20 Jan 2016

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2015: 1,153
Share of these events in Class II: 91%
Product records in this event: 4Median of the firm: 1
Events of the firm on the register: 105

Other events of the firm

Other FDA enforcement events of Ortho-Clinical Diagnostics
Initiated	Product (first record)	Type	Class	Records
27 Feb 2024	VITROS Performance Verifier I	Device	Class II	2
5 Jun 2023	VITROS Immunodiagnostic Products Troponin I ES Reagent Pack	Device	Class II	2
8 May 2023	VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- U	Device	Class II	1
20 Jul 2020	VITROS XT3400 Chemistry System, Product code 6844458	Device	Class II	2
17 Jul 2020	VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage:	Device	Class II	2
13 Jul 2020	VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL)	Device	Class II	3
20 May 2020	VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750	Device	Class II	5
11 May 2020	VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Prod	Device	Class II	4
1 Apr 2020	VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 -	Device	Class II	2
10 Mar 2020	VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468	Device	Class III	1

Ortho-Clinical Diagnostics: all 105 events

Official channels

FDA enforcement report Z-0640-2016The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 72597. https://recallregister.com/fda/ii/72597/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution - US Nationwide and the countries of Puerto Rico, and foreign distribution to: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India,…
What quantity of product is in FDA event 72597?: The event has 4 product records. The first record gives this quantity: Domestic: 200, Foreign: 554
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2015 have the same class?: 91% of the 1,153 device events that started in 2015 are in Class II.