FDA Enforcement
Class II
Terminated
VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296
Recall: Z-2875-2020
·
Reported September 2, 2020
Enforcement
- Recall Number
- Z-2875-2020
- Event ID
- 86070
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ortho-Clinical Diagnostics
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- September 2, 2020
- Initiation Date
- July 13, 2020
- Classification Date
- August 24, 2020
- Termination Date
- July 27, 2021
- Address
- 513 Technology Blvd, N/A, Rochester, NY, 14626-3601, United States
Description
VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296
Reason
Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
Code Info
All Current, Future and Past Lots UDI: 10758750031801
Distribution
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.
Quantity
US= 4076 OUS=949