FDA Enforcement
Class II
Terminated
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.
Recall: Z-1931-2020
·
Reported May 20, 2020
Enforcement
- Recall Number
- Z-1931-2020
- Event ID
- 85363
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ortho-Clinical Diagnostics
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 20, 2020
- Initiation Date
- April 1, 2020
- Classification Date
- May 8, 2020
- Termination Date
- January 19, 2021
- Address
- 513 Technology Blvd, N/A, Rochester, NY, 14626-3601, United States
Description
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.
Reason
The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.
Code Info
CKMB Slides that expire after July 20, 2018 and within current expiry.
Distribution
US Nationwide distribution.
Quantity
N/A