Z-1007-2025Class II

Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New)...

Name: Z-1007-2025 Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New)...
Creator: Ortho-Clinical Diagnostics, INc.
Published: 2024-12-19
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2024-12-19 / Open, Classified / root cause: software

FDA source

Ortho-Clinical Diagnostics, INc. began a recall of Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China)... on 2024-12-19. FDA classified it as Class II and gives the reason as "The VITROS 3600 Immunodiagnostic 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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1007-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-19
Posted: 2025-01-21
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (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
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The VITROS 3600 Immunodiagnostic 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.
Root cause tag: software
FDA root cause: Software Design Change
Action: 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.
Quantity in commerce: 981 units (99 US, 882 OUS)
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 codes and lots: Lot Code: VITROS 3600 Immunodiagnostic System Product Code: 6802783 (New) UDI: 10758750002979 VITROS 3600 Immunodiagnostic System (Certified/Refurbished) Product Code: 6802914 UDI: 10758750002979 VITROS 3600 Immunodiagnostic System (China) Product Code: 6904000 UDI: 10758750035779 Range of installed serial numbers:36000004-36001776 Manufacture date range: June 2008 to present Distribution date range; June 2008 to present Total systems currently installed in the US: 99 Total systems currently installed outside the US: 882 Note1: The catalogue number 6802783 is used to denote the VITROS 3600 Immunodiagnostic System. Catalogue number 6802914 is used to denote the VITROS 3600 Immunodiagnostic System that have been refurbished, these systems can also be referred to as certified. A VITROS 3600 Immunodiagnostic System Certified/Refurbished 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1007-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1005-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-21
Z-1006-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-21
Z-1007-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-21

Product code JJE

K083173Class IIVitros Immunodiagnostic Products Tsh Reagent Pack and Calibrators, Vitros 3600 Immunodiagnostic SystemOrtho-Clinical Diagnostics / cleared 2008-12-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)