Z-2266-2024Class II

VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS...

Name: Z-2266-2024 VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS...
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2024-05-21
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2024-05-21 / Open, Classified

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Products FS Diluent Pack 3 comes with 3 packs... on 2024-05-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2266-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-21
Posted: 2024-07-03
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: PPM General Purpose Reagent
Reason for recall: 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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 1000
Distribution: Worldwide - US Nationwide distribution in the states of FL, IL, NY, PA and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Spain, Singapore, Sweden, The Netherlands, United Kingdom.
Product codes and lots: Lot Code: Model No 6801754; UDI-DI 10758750007004; Lot Number 01-1645; Expiration Date: 05-Jul-2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2266-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2266-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-07-03

Product code PPM

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)