Ortho-Clinical Diagnostics, Inc. VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Products FS Diluent Pack 3 comes with 3 packs per sales unit. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Products FS Diluent Pack 3 comes with 3 packs per sales unit.
Brand
Ortho-Clinical Diagnostics, Inc.
Lot Codes / Batch Numbers
Lot Code: Model No 6801754, UDI-DI 10758750007004, Lot Number 01-1645, Expiration Date: 05-Jul-2024
Products Sold
Lot Code: Model No 6801754; UDI-DI 10758750007004; Lot Number 01-1645; Expiration Date: 05-Jul-2024
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VIT due to VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VIT. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.
Recommended Action
Per FDA guidance
An URGENT PRODUCT CORRECTION NOTIFICATION dated 5/31/24 was sent to customers. REQUIRED ACTIONS " Discontinue using, render unusable, and discard your remaining inventory of VITROS FS Diluent Pack 3, Lot 01-1645, including packs currently loaded on your VITROS System(s). " Complete and return the enclosed Confirmation of Receipt form no later than June 10, 2024. Upon receipt of your completed Confirmation of Receipt form, QuidelOrtho will credit or replace your discarded inventory. " Save this notification with your User Documentation or post this notification by each VITROS 5,1 FS/4600/5600/XT 7600 System until the issue has been resolved. " Please forward this notification if the affected product was distributed outside of your facility. " If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Global Services Organization. DISTRIBUTOR REQUIRED ACTIONS " Discard your remaining inventory of VITROS FS Diluent Pack 3, Lot 01-1645. QuidelOrtho will credit your account. " Send the enclosed customer letter and customer Confirmation of Receipt form to all customers who were shipped VITROS FS Diluent Pack 3, Lot 01-1645, from your facility. " Complete and return the enclosed distributor Confirmation of Receipt form no later than June 10, 2024. " Please forward this notification if the affected product was distributed outside of your facility. Contact Information We apologize for the inconvenience this may cause your facility. If you have further questions, please contact Global Services Organization at 1-800-421-3311.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026