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Recall Observatory FDA recall evidence

Device 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.

Z-2266-2024

May 21, 2024

Class II

Product summary

Firm
Ortho-Clinical Diagnostics, Inc.
Event
Event 94770
Status
Ongoing
Classification
Class II
Quantity
1000
Official record key
device-enforcement:Z-2266-2024

Official wording

Reason: 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.

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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.