Recall Z-1931-2020— Ortho-Clinical Diagnostics

Name: FDA recall Z-1931-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-01

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2020-04-01, terminated 2021-01-19. It names one FDA 510(k) clearance: K861387. Product: 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..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2020-04-01
Terminated: 2021-01-19
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K861387 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB)Eastman Kodak Company·cleared 1986-06-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.