Official recall record
Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished),
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-12-19
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 10758750002979
- Brand on record
- Ortho-Clinical Diagnostics, INc.
- Product category
- Medical Device
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 5 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2018-10-19 · US FDA — Medical Devices
VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a va - 2020-05-20 · US FDA — Medical Devices
VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 1075875 - 2016-04-06 · US FDA — Medical Devices
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and - 2024-01-22 · US FDA — Medical Devices
VITROS 3600 Immunodiagnostic System (New and Refurbished) - 2024-01-26 · US FDA — Medical Devices
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
Other recalls from this brand
- 2024-12-19 · US FDA — Medical Devices
Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 62722 - 2024-12-19 · US FDA — Medical Devices
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415
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