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Ortho Clinical Diagnostics Inc Recall 87019

Description: VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems Product Code: 6844293

Ortho Clinical Diagnostics Inc Recall 87019 Information

StatusTerminated
Mandated?Voluntary: Firm initiated
Recall NumberZ-0845-2021
Event ID87019
Event DescriptionVITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems Product Code: 6844293
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution and the countries of AR, AU, BM, BR, CA, CL, CN, CO, CR, DO, EC, FR, FR, GT, HT, IN, JP, MX, PA, PE, PR, PY, SV.
QuantityUS=9802; OUS: 1298 Total: 11,100
Recall ReasonEltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
Device Classification20210120
Device Code InfoAll Current, Future and Past Lots UDI: 10758750031771
Center Classification Date20210112
Recall Initiation Date20201215
Recalling FirmOrtho Clinical Diagnostics Inc
Initial Notification Letter
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