Ortho-Clinical Diagnostics: Medical Device Recall in 2020 - (Recall #: Z-1931-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 1, 2020

Date Posted: May 20, 2020

Recall Number: Z-1931-2020

Event ID: 85363

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.

Status: Terminated

Product Quantity: N/A

Code Information:

CKMB Slides that expire after July 20, 2018 and within current expiry.

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated