Z-1931-2020 Class II Terminated
FDA device recall Z-1931-2020 was initiated by Ortho-Clinical Diagnostics on April 1, 2020 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated January 19, 2021). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- April 1, 2020
- Termination Date
- January 19, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product 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 for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
CKMB Slides that expire after July 20, 2018 and within current expiry.