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

FDA device recall Z-2266-2024 · posted 2024-07-03 · Open, Classified

Recall details

Recalling firm

Ortho-Clinical Diagnostics, Inc.

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

PPM

Quantity affected

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,

Date initiated

2024-05-21

Date posted

2024-07-03

Location

Rochester, NY