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VITROS recallZ-2266-2024 · Ortho-Clinical Diagnostics, Inc. · initiated May 21, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ortho-Clinical Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-2266-2024
Status
Open, Classified
Initiated by the company
May 21, 2024
Posted by the FDA
Jul 3, 2024
Recalling firm
Ortho-Clinical Diagnostics, Inc.
Quantity
1000
Product code
PPM
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 description

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.

Code information (models, lots, serial numbers)

Lot Code: Model No 6801754; UDI-DI 10758750007004; Lot Number 01-1645; Expiration Date: 05-Jul-2024

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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