Recall Z-3280-2018— Ortho-Clinical Diagnostics

Name: FDA recall Z-3280-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-05

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2018-05-05, terminated 2021-02-19. It names one FDA 510(k) clearance: K924471. Product: VITROS Sodium Slides, Catalog # 837 9034. Reason: Potential for positively biased results.

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2018-05-05
Terminated: 2021-02-19
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K924471 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL)Eastman Kodak Company·cleared 1992-11-06

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 Sodium Slides, Catalog # 837 9034

Reason for recall

Potential for positively biased results

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