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FDA (Device enforcement)Recalled 2024-05-21class ii

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 sa

Hazard

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.

Details from the source

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. 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. Quantity: 1000 Lot/code info: Lot Code: Model No 6801754; UDI-DI 10758750007004; Lot Number 01-1645; Expiration Date: 05-Jul-2024

UPC codes

10758750007004

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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