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RecallWatchMedical Device Safety
Class IIOngoingZ-1005-2025

Ortho-Clinical Diagnostics, INc. recalls Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number:…

Ortho-Clinical Diagnostics, INc.Rochester, NY, United StatesReported Jan 29, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component

Lot / code information

Lot #
Code: VITROS 5600 Integrated System (New) Product Code: 6802413
UDI
10758750002740 VITROS 5600 Integrated System (Certified/Refurbished) Product Code: 6802915
UDI
10758750002740
Lot #
Code: VITROS 5600 Integrated System (China) Product Code: 6904001
UDI
10758750035786 Range of installed
Serial #
56000015-56004962 Manufacture date range: August 2008 to present Distribution date range; August 2008 to present Total systems currently installed in the US: 905 Total systems currently installed out…Show all
56000015-56004962 Manufacture date range: August 2008 to present Distribution date range; August 2008 to present Total systems currently installed in the US: 905 Total systems currently installed outside the US:2344 Note1: The
Catalog #
6802413 is used to denote the VITROS 5600 Integrated System
Catalog #
6802415 is used to denote those VITROS 5600 Integrated Systems that have been refurbished, these systems can also be referred to as certified. A VITROS 5600 Integrated System maintains its original
Serial #
through the refurbishment/certification process. Therefore, the manufacturing and distribution information for the two
Catalog #
will be combined. Note2: When manufactured the system s
Show 4 more code fields
Serial #
are sequential, but not all analyzers are released for distribution and therefore not installed. The range of
Serial #
provided includes the identified minimum and maximum in
Serial #
associated with all currently installed systems. Therefore, the amount of each system manufactured may not equal the amount of each system installed. Additionally, not all
Serial #
listed are associated with an active installed analyzer in use today. Note3: The value given for "Product Quantity Distributed" is the total number of active installed systems that are in use toda…Show all
listed are associated with an active installed analyzer in use today. Note3: The value given for "Product Quantity Distributed" is the total number of active installed systems that are in use today. This number is known to fluctuate as individual systems are installed and/or decommissioned

What the firm is doing

On December 19, 2024 URGENT PRODUCT CORRECTION NOTIFICATION letters were sent to customers. REQUIRED ACTION " Do not use expired Signal Reagent packs. See the Questions & Answers section for more details. " Complete the enclosed Confirmation of Receipt form no later than December 31, 2024. " Save this notification with your User Documentation or post this notification by each VITROS 3600/5600/XT 7600 System in your laboratory until the issue has been resolved. Contact Information We apologize for the inconvenience this will cause your laboratory. If you have further questions, please contact Global Services Organization at 1-800-421-3311. To report adverse events, contact your local Global Services Organization. Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program: www.fda.gov/medwatch/report.htm, 1-800-332-1088.

DistributionShow details

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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