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VITROS recallZ-1005-2025 · Ortho-Clinical Diagnostics, INc. · initiated Dec 19, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ortho-Clinical Diagnostics, INc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software Design Change

What the company 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.

Recall details

Recall number
Z-1005-2025
Status
Open, Classified
Initiated by the company
Dec 19, 2024
Posted by the FDA
Jan 21, 2025
Recalling firm
Ortho-Clinical Diagnostics, INc.
Quantity
3,249 units (905 US, 2,344 OUS)
Product code
JJE
FDA submissions
K081543
Distribution
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.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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 numbers: 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 catalogue number 6802413 is used to denote the VITROS 5600 Integrated System. Catalogue number 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 number through the refurbishment/certification process. Therefore, the manufacturing and distribution information for the two catalogue numbers will be combined. Note2: When manufactured the system s serial numbers are sequential, but not all analyzers are released for distribution and therefore not installed. The range of serial numbers provided includes the identified minimum and maximum in serial numbers 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 numbers 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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 96031).

Sources and updates

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