Recall Z-2879-2020— Ortho Clinical Diagnostics

Name: FDA recall Z-2879-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-20

Class II · Terminated

Class II FDA medical device recall by Ortho Clinical Diagnostics, initiated 2020-07-20, terminated 2023-12-18. It names one FDA 510(k) clearance: K182063. Product: VITROS XT7600 Integrated System, Product code 6844461. Reason: When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results..

Recalling firm: Ortho Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2020-07-20
Terminated: 2023-12-18
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K182063 — VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated SystemOrtho-Clinical Diagnostics, Inc.·cleared 2018-10-30

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 XT7600 Integrated System, Product code 6844461

Reason for recall

When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.

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