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.
This recall has been terminated (originally issued April 1, 2020).
- Company
- Ortho-Clinical Diagnostics
- Recall Initiated
- April 1, 2020
- Terminated
- January 19, 2021
- Recall Number
- Z-1931-2020
- Firm Location
- Rochester, NY
- Official Source
- View on FDA website ↗
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
US Nationwide distribution.
Lot / Code Info
CKMB Slides that expire after July 20, 2018 and within current expiry.
Root Cause
Labeling design
Action Taken
An Urgent Product Correction letter was sent on April 1, 2020 to affected customers stating that the Spanish and Swedish IFU versions for the VITROS CK-MB slides incorrectly included plasma as a sample type in the Intended Use section. Customers were instructed to complete and return the Confirmation of Receipt form then, determine whether the effected IFUs were being used in their laboratory and identify any plasma samples that were taken while using those instructions for use. The laboratory directors should determine how to handle the assays that used plasma samples. The firm directed customers to go to the Ortho-Clinical Diagnostics website to download the updated Spanish and Swedish IFUs.