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Recall Observatory FDA recall evidence

Device product

VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma, Product code: 8383051 (60 slide); 1612365 (18 slide)

Z-2874-2020

July 13, 2020

Class II

Product summary

Firm
Ortho-Clinical Diagnostics
Event
Event 86070
Status
Terminated
Classification
Class II
Quantity
80351:US=35113; OUS: OUS=1593941.1612365: US=20068; OUS= 35534
Official record key
device-enforcement:Z-2874-2020

Official wording

Reason: Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides

Code information: All Current, Future and Past Lots UDI: 10758750004829, 10758750009398

Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Bermuda HM08, Brazil, Canada L3R 4G5, China, Denmark, France, Germany, Italy, Mexico, Norway, Poland, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides