Recall Z-0770-2021— Ortho Clinical Diagnostics Inc

Name: FDA recall Z-0770-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-11

Class II · Ongoing

Class II FDA medical device recall by Ortho Clinical Diagnostics Inc, initiated 2020-12-11. It names one FDA 510(k) clearance: K861387. Product: VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartridge) Product Code: 8001133 Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.. Reason: VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference.

Recalling firm: Ortho Clinical Diagnostics Inc
Classification: Class II
Status: Ongoing
Initiated: 2020-12-11
Firm location: Raritan, NJ, 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: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartridge) Product Code: 8001133 Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.

Reason for recall

VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference

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